Can a plasma-based treatment boost Gilead's remdesivir? NIH starts phase 3 trial to find out

Can a plasma-based treatment boost Gilead’s remdesivir? NIH starts phase 3 trial to find out

  • October 9, 2020

When the first placebo-controlled data for Gilead’s remdesivir came out, analysts agreed it was no “silver bullet” for COVID-19. But it didn’t have to be, said Gilead CEO Daniel O’Day, who saw it as a stepping stone to other treatments and one that could even be combined to work better. Now, the National Institutes of Health will test that theory as it kicks off a global study pairing the antiviral drug with plasma-based treatments.

The phase 3 trial will pit the combination against remdesivir plus placebo in 500 adult patients who have been hospitalized with COVID-19. It will take place in 18 countries across the globe and will assess patients’ health status after seven days of treatment. The patients will have had symptoms for 12 days or fewer, and not suffer from life-threatening organ dysfunction or organ failure. If all goes to plan, investigators will follow patients for 28 days.

Several companies will provide the plasma-based treatments: Emergent BioSolutions and Grifols will supply one, while a Takeda and CSL-Behring led group, dubbed the CoVIg-19 Plasma Alliance, will provide the other treatment, called CoVIg-19.

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RELATED: Takeda, CSL-led alliance and NIH to test COVID-19 plasma treatment this summer

Known as hyperimmune globulins, the treatments are made by purifying antibodies from plasma donated by people who have recovered from COVID-19. Because it is purified and concentrated, the plasma carries much higher levels of neutralizing antibodies than patients who have survived infection do. The investigators figure that giving patients the treatment when symptoms first appear, but before the body has had a chance to make its own antibodies, could boost patients’ immune response to SARS-CoV-2, the virus that causes COVID-19.

“Finding safe and effective treatments for COVID-19 is absolutely critical,” Anthony Fauci, M.D., director of the NIH’s National Institute of Allergy and Infectious Diseases, said in a statement. “The ITAC trial will examine whether adding anti-coronavirus hIVIG to a remdesivir regimen can give the immune system a needed boost to suppress SARS-CoV-2 early in the course of illness, nipping the infection in the bud.” 

RELATED: Takeda, CSL-led plasma players band together on COVID-19

Before forming the alliance, Takeda started working on its own hyperimmune globulin against the coronavirus, but it quickly realized that joining forces with other plasma players would be the fastest way to a treatment. The group includes companies from Australia, the U.K., Switzerland, Germany and France.

RELATED: COVID-19 close-up: Takeda’s Morabito on the science behind plasma-based treatments

“The rapid progress we’ve made since we initiated this program just a few months ago to reach this key milestone of enrolling patients in the trial is a powerful testament to the collaboration, determination and innovation taking place across the biomedical community as we work to fight the COVID-19 pandemic,” Julie Kim, president of Takeda’s plasma-derived therapies unit and co-leader of the CoVIg-19 Alliance, said in a statement.

“This study will help us understand how CoVIg-19 could potentially become an important therapeutic option,” Kim added. “To support our efforts, we encourage all those people who have recovered from COVID-19 to donate their plasma, which contains vital antibodies that have fought off the disease and could help others do the same.”

The CoVIg-19 Alliance hopes to see the study read out by the end of the year, Bill Mezzanotte, M.D., the group’s other co-leader and CSL Behring’s chief medical officer and R&D chief, said in the statement.

Dexamethasone: Steroid given to President Trump for COVID-19 treatment prompts concern in medical community

Dexamethasone: Steroid given to President Trump for COVID-19 treatment prompts concern in medical community

  • October 8, 2020
Earlier this week, President Trump returned to the White House after a three-day stay at Walter Reed Medical Center following his COVID-19 diagnosis, prompting concerns from many in the medical community.

Among the questions being raised: Could the steroid medication he’s been given account for his sense of well-being? And what are the potential side effects associated with it?

A day after he was discharged from the hospital, the president tweeted that he was “FEELING GREAT!”

Among an extensive cocktail of medications he was administered, the president received a powerful steroid called Dexamethasone which can give you a heightened sense of well-being.

Emergency Medicine physician Dr. Michael Daignault says dexamethasone can make you more sensitive to the actions of adrenaline.

“You’re going to feel a little more inspired. A little more robust than you potentially actually are,” he said. “If you have those steroids, the adrenaline becomes more up-regulated.”

Regeneron: Experimental drug used on Trump also being tested in Southland

In very rare cases, it can bring on depression and psychosis.

Early on in the pandemic, doctors learned the inexpensive anti-inflammatory medication can help reduce the runaway inflammation that eventually leads to death.

“Dexamethasone is a great drug but you really have to time it appropriately,” Daignault said.

Studies suggest it should only be administered when your body’s natural defenses start to get overcome.

“That’s when we give the dexamethasone, to help your immune system. To give it a little bit of a boost, to rev it back up. If you give it too early on, you’re going to blunt your own immune system’s response to the virus and that’s potentially dangerous,” he said.

The guidance for dexamethasone is very specific.

“It’s a 10-day course or less, if you’re being discharged from the hospital,” Daignault said.

The steroid is reserved for hospitalized patients with lung inflammation and need oxygen assistance. Daignault says the president’s doctors must have had strong reason to justify the use of such a powerful medication.

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The Scientist Magazine®

What We Know About Donald Trump’s COVID-19 Treatment Plan

  • October 5, 2020

On Thursday, October 3, it was announced that President Donald Trump, First Lady Melania Trump, and other White House officials had tested positive for SARS-CoV-2. His symptoms worsened and on Friday evening, he was admitted to Walter Reed National Military Medical Center in Bethesda, Maryland. 

There has been some mixed messaging with the actual timeline of when he received his diagnosis and began a treatment regimen, as The New York Times reports, and doctors can only speculate on his prognosis.

Here is what is currently known about the drugs Trump has been taking to combat his illness:

One of the first reported treatments Trump received was an experimental cocktail of two monoclonal antibodies from Regeneron. Trump was intravenously given eight grams of the cocktail, which is the highest dose used during the drug’s small, 245-person clinical trial. According to a September press release from Regeneron, the drug is meant to treat non-hospitalized patients and boost the patient’s immune response, decreasing viral load. 

On Friday, Trump also received his first dose of remdesivir, a drug originally developed to treat Ebola infections. Prior to the pandemic, it was shown in vitro to be effective against the coronaviruses that cause SARS and MERS, suggesting it could be effective against SARS-CoV-2. Further testing of the drug in COVID-19 patients, given over the course of five days, showed that it was effective in treating severe disease in patients with pneumonia receiving supplemental oxygen. In late August, the drug received emergency use authorization by the U.S. Food and Drug Association for patients with severe cases.

On Saturday, Trump received dexamethasone, a corticosteroid that mitigates inflammation in the lungs and tempers the patient’s immune system. The drug has a long history of use for a wide variety of ailments, including autoimmune diseases, cancer, and certain endocrine disorders, and has been on the World Health Organization’s list of essential medications since 1977. Over the summer, a study showed that the drug is also useful in treating severe COVID-19, reducing the mortality rate by 20 percent.

“I think we were all astonished to see how effective it was,” the University of Oxford’s Richard Haynes, who is one of the leaders of the trial, wrote in an email to The Scientist in June. “We tested it because we believed it could be effective, but I don’t think anyone was expecting to see quite such large effects.”

As reported by the Times, the President was receiving supplemental oxygen when his levels dipped below 95 percent. 

An October 2 memo from Trump’s physician reveals that in addition to these interventions, he has also been taking daily aspirin, melatonin (a supplement to aid in sleep), zinc, and famotidine, an antacid sold under the tradename Pepcid. 

The memo also noted that Trump has been given vitamin D supplements. In August, a study found a connection to low vitamin D levels and susceptibility to COVID-19. It is not clear if these supplements are part of routine health maintenance or his coronavirus infection care.

Notably absent from the President’s treatment plan is hydroxychloroquine, an anti-malarial that Trump has touted as a promising treatment throughout the COVID-19 pandemic, even after it was shown to be largely ineffective and potentially harmful. In May, Trump claimed to have taken a two-week-long preventive dose of the drug. In late July, he was still tweeting about the drug, long after its emergency use authorization had been rescinded. The tweet has since been deleted.

Trump’s Covid-19 Treatment Seeks to Boost Immune Response

Trump’s Covid-19 Treatment Seeks to Boost Immune Response

  • October 5, 2020

The experimental infusion doctors have given to President Trump seeks to counter a problem affecting many older Covid-19 patients: an ineffective immune response.

Among other treatments, Mr. Trump has taken a drug cocktail from

Regeneron Pharmaceuticals Inc.


REGN 5.69%

that hasn’t been approved for broad use but aims to jump-start an immune defense by supplying antibodies to help fight the coronavirus that causes Covid-19. The company says its results suggest the infusion can help people infected with the coronavirus who haven’t yet produced their own antibodies.

The approach makes sense in elderly patients, whose bodies are often less able to fight off pathogens, said Janko Nikolich-Zugich, an immunologist and gerontologist who is a professor at the University of Arizona. “You don’t control the virus as quickly as you should” with older patients, he said.

A growing body of research points to the immune system as a key reason why the elderly are so susceptible to serious cases of Covid-19. As a person ages, the system undergoes “immunosenescence,” gradually losing its ability to mount a response to infection as robustly as it once did. The complicated mechanisms of the immune system don’t work together as well, leading to a slower and less-powerful defense.

In addition to his age, 74, Mr. Trump’s weight also may raise concerns about his immunity, as obesity has been tied to impaired response. And a study published in the journal Nature this August also highlighted the possibility that older men, in particular, might tend to mount a less-robust immune response to the virus.

The President’s Medical Treatment

About 80% of deaths in the U.S. have been among those 65 and older, and about 31% of deaths are among people aged at least 85 years, according to death-certificate data from the Centers for Disease Control and Prevention. This is partly because the elderly are often frailer, and they also have higher rates of conditions such as heart disease and diabetes that are risk factors for severe impact from Covid-19.

But their immune systems are another important factor, researchers say. “When you challenge a body with a virus or a vaccine, there’s just not the vigorous response,” said Cari Levy, a geriatrician who is a professor at the University of Colorado.

Older people often produce fewer, and less-effective, antibodies. These y-shaped proteins are supposed to bind to invading pathogens, neutralizing them and signaling to the body to destroy them.

“It’s slower, it’s unreliable—you probably don’t make as many” antibodies, said Peter Chin-Hong, a professor of medicine at the University of California, San Francisco. The hope is that treatments like Regeneron’s experimental cocktail might help fill that gap early in the infection process, potentially slowing the initial spread of the virus.

Elderly immune systems also often have problems generating the powerful soldiers known as T-cells, which supply a main line of defense against invaders. Production of these cells, from a gland in the chest known as the thymus, drops sharply over the course of a person’s life. They can also lose some of their function.

One recent study suggests that older men have a harder time getting their T-cells into action. New research published this August in Nature looked at 98 patients infected with the coronavirus and found evidence that the immune response varied by gender.

“Especially men of older age were very impaired with respect to T-cell activation,” said Akiko Iwasaki, a professor of immunobiology at Yale University who led the study. Those men who had the least T-cell response tended to have worse Covid-19 outcomes, she said.

There is no treatment currently available that would help with Covid-19 patients’ T-cells, she said. Potentially a future vaccine might do this, but vaccines are often less effective in older patients.

But even as vital parts of an elderly person’s immune system are performing sluggishly, another response can cause trouble by firing up too much. As the body fails to contain the virus quickly, the immune system may produce too many of a type of protein called cytokines. These can damage blood vessels and allow fluid to seep into the lungs.

It isn’t clear why this “cytokine storm” effect is triggered in some patients but not others. But elderly people tend to have a higher level of inflammation, and cytokines, said Amber Mueller, a molecular biologist who is a postdoctoral research fellow at Harvard Medical School.

This greater baseline level of inflammation is one reason the soldier T-cells are less effective, and it sets the stage for the dangerous overproduction of cytokines, she said.

President Trump remained hospitalized early Monday, after doctors offered conflicting signals about how he is faring with Covid-19. The president sought to project confidence and vigor over the weekend.

Write to Anna Wilde Mathews at anna.mathews@wsj.com

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Remdesivir Treatment Well Known To Area Infectious Disease Experts – NBC Connecticut

Remdesivir Treatment Well Known To Area Infectious Disease Experts – NBC Connecticut

  • October 4, 2020

What is Remdesivir and why is the president being treated with it? Those are questions on many American’s minds as President Donald Trump undergoes treatment for COVID-19.

Although Remdesivir has been described as an experimental medicine, it’s more common than some might expect. According to Dr. David Banach, an infectious disease expert and epidemiologist at UConn’s John Dempsey Hospital, it has been used for months.

“It had been used in a clinical trial but more recently it had been approved through emergency use authorization by the FDA,” said Banach.

Banach said any hospitalized patient with COVID-19 can get Remdesivir. The antibody cocktail is delivered intravenously and works to directly attack the virus.

“It’s administered to patients who have COVID-19 in order to dramatically reduce the amount of virus that is circulating in the body,” said Banach, explaining it can only be given to hospitalized patients.

Dr. Helen Boucher, Chief of Infectious diseases at Tufts Medical Center in Boston, took part in the clinical trials for Remdesivir. Data published in May indicated the drug lessened the length of a patients’ hospital stays on average by about four days.

“What we know is that patients treated with Remdesivir get better, faster,” said Boucher.

According to the president’s physician, Dr. Sean Conley on Saturday morning, the resident is not currently on oxygen. Boucher, though, said this drug is normally used on patients who are.

“In general, Remdesivir is recommended when patients have moderate to severe COVID-19. When they need oxygen supplementation, where their oxygen saturation is below 94%,” said Boucher.

Banach said Remdesivir is normally used in the early stages of the disease and on sicker patients but said this may not be a reflection on the president’s condition.

“It can be given to any patient who is hospitalized. So, I don’t think it’s easy to make any concrete conclusions simply based on the fact that he’s getting this medication,” said Banach.

In addition, Trump is being treated with monoclonal antibodies to boost his immune system. These are antibodies that specifically target the germs that cause the COVID-19 virus.

“Remdesivir has activity in which it directly kills the virus. Where the monoclonal antibodies are basically the antibodies that we all produce in response to infection,” Banach explained.

According to Dr. Sean Conley, the president will receive this antiviral treatment for five days. He was given the first dosage at Walter Reed Hospital on Friday.

Trump receiving remdesivir antiviral drug as part of experimental treatment

Trump receiving remdesivir antiviral drug as part of experimental treatment

  • October 3, 2020

President Donald Trump is receiving an experimental antiviral for Covid-19 called remdesivir as he remains hospitalized at Walter Reed National Military Medical Center in Bethesda, Maryland. The drug is being given as part of a double-barreled treatment plan that includes an antibody cocktail meant to give the president’s immune system a boost to fight off the coronavirus.

The president was given the first dose of remdesivir Friday evening and will be on a five-day course of the IV drug, his physician, Dr. Sean Conley, said during a news conference Saturday.

Full coverage of the coronavirus outbreak

Remdesivir, manufactured by Gilead Sciences, works by lowering the amount of virus in the body. Clinical trial data published in May found that the drug reduced patients’ length of hospital stay by about four days, from 15 days to a median of 11 days.

In July, additional data showed remdesivir may reduce deaths.

“It’s not really a treatment in the sense that it’ll cure people,” Dr. Irwin Redlener, director of the Pandemic Resource and Response Initiative at Columbia University’s National Center for Disaster Preparedness, said Saturday on MSNBC. “It will just hopefully reduce the fatality rate and reduce the course of the illness.”

Remdesivir is generally used for patients who need supplemental oxygen, although Conley said Trump did not need help breathing Saturday morning. When pressed during the briefing about whether the president had ever received supplemental oxygen, Conley persistently said the president had not received oxygen on Thursday or while at Walter Reed on Friday and Saturday.

It was unclear whether the president needed oxygen at another time.

We are maximizing all aspects of his care, attacking this virus with a multi-pronged approach.

Conley told reporters Saturday that Trump is doing “very well” but the coming days will be critical to the president’s recovery.

“With the known course of the illness, day seven to 10, we get really concerned about the inflammatory phase, phase two,” Conley said. “Given that we provided some of these advanced therapies so early in the course, a little bit earlier than most of the patients we know and follow, it’s hard to tell where he is on that course.”

Not the usual care

In addition to remdesivir, the president has received a combination antibody treatment. It’s a cocktail of two monoclonal antibodies. Antibodies act by recognizing specific germs — in this case, SARS-CoV-2, the virus that causes Covid-19 — and harnessing the immune system to fight them off.

“We are maximizing all aspects of his care, attacking this virus with a multi-pronged approach,” Conley said. “He’s the president, and I didn’t want to hold anything back. If there was any possibility that it would add value to his care and expedite his return, I wanted to take it.”

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The double-barreled approach is not usual care for patients in the president’s condition, especially since both treatments are still in clinical trial.

But in theory, the two would work “synergistically,” said Dr. Hugh Cassiere, director of critical care services for Sandra Atlas Bass Heart Hospital at North Shore University Hospital, part of Northwell Health, on Long Island, New York.

“The remdesivir is supposed to stop viral replication, but if there is some virus that does replicate, the monoclonal antibodies would mop that up,” Cassiere said, adding that both drugs appear to be safe.

It is unclear when or even if the Food and Drug Administration will ultimately approve either treatment. The FDA issued an emergency use authorization for remdesivir, and the monoclonal antibodies were given under what’s known as compassionate use.

Given what’s known so far about both treatments, Cassiere predicted they will someday become standard.

The president, he said, “is getting a standard of care months before anyone else.”

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Trump receives experimental antibody treatment for Covid-19 diagnosis

Trump receives experimental antibody treatment for Covid-19 diagnosis

  • October 3, 2020

President Donald Trump has received an experimental drug following his diagnosis of Covid-19, the White House said Friday.

“As a precautionary measure, he received a single 8 gram dose of Regeneron’s polyclonal antibody cocktail. He completed the infusion without incident,” Dr. Sean Conley, the president’s physician, wrote in a memorandum.

Full coverage of the coronavirus outbreak

The drug cocktail is a combination of two so-called monoclonal antibodies. The treatment is meant to provide the body’s immune system with a temporary, but immediate, boost to fight off the coronavirus.

Monoclonal antibodies (or, in this case, polyclonal because there are two in the cocktail) are made in a lab to mimic the body’s natural antibodies. Antibodies act by recognizing specific germs — in this case, SARS-CoV-2, the virus that causes Covid-19 — and harnessing the immune system to fight them off.

The therapy, though still unproven, is considered by experts to be one of the most promising treatment options for the illness.

Regeneron confirmed it provided its drug to the president under what is called “compassionate use,” through which the Food and Drug Administration allows access to experimental drugs outside of clinical trials for patients with a life-threatening condition or serious disease.

Download the NBC News app for full coverage of the coronavirus outbreak

The treatment is currently being studied in clinical trials as a potential treatment and possible prevention of illness in people who have been exposed. The drug company said Tuesday that early evidence from the trials suggest the treatment appears to be beneficial in patients with mild to moderate illness.

“It decreased viral load, and made symptoms resolve faster,” Dr. Todd Rice, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee, said. Rice is not involved with Regeneron’s clinical trials.

Trump is said to have mild symptoms, including fatigue and a low-grade fever. As a precautionary measure, the president has been taken to Walter Reed National Military Medical Center.

The letter from the president’s physician also said Trump has been taking zinc, vitamin D, the heartburn drug famotidine, a daily aspirin and a sleep aid called melatonin. All of those are sold over the counter. There is no solid evidence any might help treat Covid-19.

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‘Provocative results’ boost hopes of antibody treatment for COVID-19 | Science

‘Provocative results’ boost hopes of antibody treatment for COVID-19 | Science

  • September 30, 2020

Companies are developing COVID-19 treatments using monoclonal antibodies, Y-shaped immune proteins that target the pandemic coronavirus.

KTSDESIGN/Science Source

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

A second company has now produced strong hints that monoclonal antibodies, synthetically produced versions of proteins made by the immune system, can work as treatments in people who are infected with the pandemic coronavirus but are not yet seriously ill.

The biotech Regeneron Pharmaceuticals has developed a cocktail of two monoclonal antibodies that attach to the surface protein of that coronavirus, SARS-CoV-2, and attempt to block it from infecting cells. Yesterday at an investor and media webcast, the firm revealed early results.

The company showed slides with detailed data from 275 infected people in a placebo-controlled trial that ultimately plans to enroll 2100 individuals who are asymptomatic or, at worst, moderately ill. The analysis divides patients into two groups: those who had detectable antibodies against SARS-CoV-2 at the trial’s start and those who did not, a so-called seronegative group. The monoclonal cocktail showed little effect on people who already had antibodies against the virus. But it appeared to help the seronegative patients, powerfully reducing the amount of virus found in nasopharyngeal swabs and alleviating symptoms more quickly. “These are provocative results,” says Myron Cohen of the University of North Carolina, Chapel Hill, who was not involved with the study but is helping Regeneron test its monoclonal cocktail as a preventive.

Cohen notes that Regeneron’s data look similar to those in a press release from Eli Lilly 2 weeks ago about early results from a trial of its single monoclonal antibody against SARS-CoV-2. “Both of these reports go in the same direction,” Cohen says. But he cautions that neither has been published, both trials are ongoing, and more data are needed to understand how—or whether—these experimental medicines can best help patients. Lilly, oddly, did not see an impact at the highest dose of antibody tested, and Regeneron saw no difference between its low- and high-dose preparations used in the study. 

James Crowe, a viroimmunologist at Vanderbilt University who is working with AstraZeneca to develop COVID-19 monoclonal antibodies, welcomed Regeneron’s detailed preliminary results. “I applaud Regeneron for releasing so much information,” Crowe says. “They’re contributing to public health by releasing this as soon as possible.” But he notes even people who did well on the monoclonal cocktail still had low levels of virus detectable after their treatment, which in theory could cause problems. “I was surprised that there was any virus at all given that these are such potent antibodies,” he says, adding that the residual virus detected in the swab tests may not be capable of copying itself.

The monoclonal antibodies from the two companies are clones of potent SARS-CoV-2 antibodies that can “neutralize” the virus in test tube studies. Researchers plucked the genes for these antibodies from humans who recovered from COVID-19 or from mice artificially infected with the virus. The companies then put the genes in Chinese hamster ovary cells to bulk manufacture the antibodies, which were given to the COVID-19 patients as infusions.

At the webcast that announced Regeneron’s results, George Yancopoulos, president and co-founder of the company, emphasized how the “target population” for the monoclonal cocktail are SARS-CoV-2 infected people who have “not yet mounted their own immune response” and have exceedingly high levels of the virus. “What we really want to do is turn them into patients who have already started to effectively fight the virus,” Yancopoulos said.

In the Regeneron data, the most dramatic drops in SARS-CoV-2 were seen in seronegative patients who had the highest levels of virus at the trial’s start. In comparison with patients who received the placebo, the results were clearly statistically significant.

Daniel Skovronsky, Lilly’s chief scientific officer, says the Regeneron data are “quite confirmatory” of their own. “I don’t expect there to be large differences between good neutralizing antibodies,” Skovronsky says. “Antibodies will work best in people who can’t clear the virus on their own.” One key difference between the two studies, he says, is that Lilly enrolled fewer seronegative people and still found an impact—although the company, in contrast to Regeneron, is withholding details until it publishes results. Lilly also stressed that people receiving its antibody were shown to have fewer hospitalizations or emergency room visits: five out of 302 (1.7%) treated patients versus nine out of 150 (6%) in the placebo group. “Yes, these are small numbers by some measures,” Skovronsky says, “but by other measures, there are significant differences in hospitalization.”

Regeneron hasn’t yet accumulated enough data to show the same protection. Its trial had only 12 patients who had “COVID-19related medically attended visits.” Although there was a trend toward more of these in the placebo group than treatment arms, only one was hospitalized.

Regeneron’s data raise difficult questions about when to use its cocktail. People who test positive for SARS-CoV-2 aren’t routinely screened for antibodies to it or for levels of the virus. “If the decision is going to be made to deploy such a therapeutic solution in the patients who might benefit the most and need it most, we’re going to have to solve the problem of using the right point-of-care diagnostic tools, either for serology or high viral load,” Yancopoulos said, noting that their partners—including Roche—are developing these types of assays.

Skovronsky says Lilly has a simpler plan: Offer monoclonals to people who test positive for the virus if they are in high-risk groups for developing severe disease, which include the elderly and people with underlying diseases such as diabetes or who are overweight. Running extra tests before treating people, as Regeneron suggests, “is just not going to meet the needs of the population,” he says

Both Lilly and Regeneron say they are discussing their data with regulators to see whether their monoclonal antibodies might warrant moving to widespread use more quickly through mechanisms like the U.S. Food and Drug Administration’s emergency use authorization process. Additional studies of their monoclonal treatments are underway in hospitalized COVID-19 patients and, separately, as preventives in uninfected people.

Monoclonal antibodies are more difficult to make than many drugs and often are extremely expensive, which means that supply could outstrip demand and many countries might not be able to afford them. The U.S. government’s Operation Warp Speed has invested $450 million in Regeneron to produce up to 300,000 “doses” of its cocktail by the end of the year, which would be distributed to Americans free of charge. “A substantial fraction of those are already available,” Yancopoulos said—although it’s not yet clear what constitutes a single dose of the company’s cocktail. Nonetheless, Regeneron, which is partnering with Roche to increase production capability, says it hopes to ramp up to produce 250,000 doses per month.

Skovronsky says if the lowest dose Lilly is testing works, it could have up to 1 million doses by the end of the year. Lilly is partnering with Amgen to scale up production to “several million doses” next year. “We’re rooting for Regeneron’s success, just as Regeneron is rooting for Lilly’s success,” he says. “None of us can make enough antibodies to meet the need.”

Researchers discover new type of antigen-presenting immune cell

Novel nasal treatment could protect people from COVID-19

  • September 30, 2020

A novel nasal treatment developed to boost the natural human immune system to fight common colds and flu, has proved remarkably successful in reducing COVID-19 viral replication test results, released today, reveal.

The novel product, INNA-051, being developed by Australian biotech company, Ena Respiratory, reduced viral replication by up to 96 percent in a gold-standard animal study led by Public Health England’s (PHE) Deputy Director, Professor Miles Carroll and now published on biomedical pre-publication research site, bioRxiv.

The INNA-051 compound works by stimulating the innate immune system, the first line of defence against the invasion of pathogens into the body. By boosting the immune response in this way with INNA-051 prior to infection, the ability of the COVID-19 virus to infect the animals and replicate was dramatically reduced the PHE study showed. The study provides evidence that INNA-051 can be used as a stand-alone method of antiviral preventative therapy, complementary to vaccine programs.

We’ve been amazed with just how effective our treatment has been. By boosting the natural immune response of the ferrets with our treatment, we’ve seen a rapid eradication of the virus. If humans respond in a similar way, the benefits of treatment are two-fold. Individuals exposed to the virus would most likely rapidly eliminate it, with the treatment ensuring that the disease does not progress beyond mild symptoms. This is particularly relevant to vulnerable members of the community. In addition, the rapidity of this response means that the infected individuals are unlikely to pass it on, meaning a swift halt to community transmission.”


Ena Respiratory Managing Director, Dr Christophe Demaison

Ena Respiratory has raised AU$11.7m from Australian investors and, subject to successful toxicity studies and regulatory approval, the company could be ready to test INNA-051 in human trials in less than four months.

Investment and support in developing the novel therapy has been led from the Australian Medical Research Commercialisation Fund (MRCF), Australia’s largest life science investment fund managed by Brandon Capital, with co-investment from university commercialization fund Uniseed. The company is urgently seeking additional funding to accelerate the nasal spray’s clinical development and global distribution.

Dr Chris Nave, CEO of the MRCF and co-founder of Brandon Capital, says these extremely promising results means INNA-051 is an exciting frontrunner in the battle to beat COVID-19. “We are doing all we can to support Ena Respiratory and its quest to secure additional investment to accelerate the development and testing of the therapy in humans. While a vaccine is ultimately the key solution to combating COVID-19, governments need to be developing different treatment approaches to ensure they have a range of options, in the event that a vaccine proves elusive or takes longer to develop.”

INNA-051 is a synthetic small molecule and would be self-administered via an easy-to-use nasal spray, taken once or twice a week, with the treatment taking almost immediate effect. If human trials are successful and, given the unprecedented need for drugs to combat COVID-19, this prophylactic immune modulation therapy could be rapidly manufactured at scale and be available for use soon.

“This is a significant development as the world races to find a solution to halt COVID-19 transmission and infection of at risk-populations,” says Professor Roberto Solari a respiratory specialist, advisor to Ena Respiratory and visiting Professor at Imperial College London. “Most exciting is the ability of INNA-051 to significantly reduce virus levels in the nose and throat, giving hope that this therapy could reduce COVID-19 transmission by infected people, especially those who may be presymptomatic or asymptomatic and thus unaware they are infectious,” Professor Solari says.

INNA-051 offers real hope to those in the frontline fight against COVID-19, says Dr Chris Smith, Ena Respiratory Board Director, and Senior Investment Manager at Brandon Capital. “The treatment offers significant potential to protect the most vulnerable, including those with pre-existing respiratory conditions and the elderly, where vaccines can be less effective.”

INNA-051 was in development before the outbreak of COVID-19 to promote resistance towards broader respiratory viral epidemics. Unlike vaccines which are targeted to a specific strain, INNA-051, is designed to be effective for all types of respiratory infections.

“Our nasal treatment has amazing potential for combating COVID-19 and future pandemics,” continues Dr Smith. We know that vaccinations are often the most attractive approach in combating respiratory virus epidemics, but this method often comes with challenges as vaccines trigger a specific response in the adaptive immune system which might not be effective against future mutations of a virus. INNA-051 utilizes the non-specific innate immune response meaning it is effective against a broad spectrum of viruses.”

“As an original investor alongside Uniseed, the MRCF saw great potential in INNA-051, before the COVID-19 era, to manage respiratory viral outbreaks, exactly like we are currently experiencing, although our initial focus was against influenza,” Dr Nave continues.  “We are now thrilled to be able to redirect the effort toward the fight against COVID-19. The treatment has significant potential, not only against this pandemic but also to play a key role in future viral respiratory outbreaks.”

The authors of the study include scientists from Public Health England (PHE), Ena Respiratory, and leading Australian research organisations, the Hunter Medical Research Institute, Newcastle and the University of Melbourne.

These are very exciting results and demonstrate the potential clinical utility of the Ena drug in the treatment of COVID-19 which will likely require multiple treatment approaches. It also underlines the value of facilitating early-stage commercialization of research, which can go on to create a global impact.”


Dr Peter Devine, CEO, Uniseed

Download an animation that explains how the treatment works here: https://innavac.box.com/s/x88k1wecf7qyowci332ar97avivsrnpx

Source:

Journal reference:

Proud, P.C., et al. (2020) Prophylactic intranasal administration of a TLR2 agonist reduces upper respiratory tract viral shedding in a SARS-CoV-2 challenge ferret model. bioRxiv. doi.org/10.1101/2020.09.25.309914.

nasal spray treatment

Could nasal spray treatment against flu increase protection to COVID-19?

  • September 28, 2020

An Australian biotech company launched a nasal spray treatment aimed to boost the human immune system, which could consequently have remarkable effects in reducing COVID-19 tests.

A novel nasal spray treatment developed to boost the natural human immune system to fight common colds and flu has proved remarkably successful in reducing COVID-19 viral replication test results, released today, reveals.

Less COVID-19 tests thanks to a nasal spray treatment?

An Australian biotech company, Ena Respiratory, developed INNA-051, a novel nasal spray treatment which reduces viral replication by up to 96 per cent in a gold-standard animal study led by Public Health England’s (PHE) Deputy Director, Professor Miles Carroll and published today on biomedical pre-publication research site, bioRxiv. It is a synthetic small molecule and would be self-administered via an easy-to-use nasal spray, taken once or twice a week

This nasal spray compound works by stimulating the human immune system by boosting the immune response in this way with INNA-051 prior to infection, the ability of the COVID-19 virus to infect the animals and replicate was dramatically reduced the PHE study showed. In particular, the study provides evidence that INNA-051 can be used as a stand-alone method of antiviral preventative therapy, complementary to vaccine programs.

In the official press release, Ena Respiratory Managing Director, Dr Christophe Demaison reports: “We’ve been amazed at just how effective our treatment has been. By boosting the natural immune response of the ferrets with our treatment, we’ve seen a rapid eradication of the virus. If humans respond in a similar way, the benefits of treatment are two-fold. Individuals exposed to the virus would most likely rapidly eliminate it, with the treatment ensuring that the disease does not progress beyond mild symptoms. This is particularly relevant to vulnerable members of the community. In addition, the rapidity of this response means that the infected individuals are unlikely to pass it on, meaning a swift halt to community transmission.”

Could the nasal spray treatment be distributed worldwide?

The company is urgently seeking additional funding to accelerate the nasal spray’s clinical development and global distribution. Dr Chris Nave, CEO of the MRCF and co-founder of Brandon Capital, reports “We are doing all we can to support Ena Respiratory and its quest to secure additional investment to accelerate the development and testing of the therapy in humans. While a vaccine is ultimately the key solution to combatting COVID-19, governments need to be developing different treatment approaches to ensure they have a range of options, in the event that a vaccine proves elusive or takes longer to develop.”

On the other hand, Professor Roberto Solari a respiratory specialist, advisor to Ena Respiratory and visiting Professor at Imperial College London contributed to these statements by saying that “this is a significant development as the world races to find a solution to halt COVID-19 transmission and infection of at risk-populations. Most exciting is the ability of INNA-051 to significantly reduce virus levels in the nose and throat, giving hope that this therapy could reduce COVID-19 transmission by infected people, especially those who may be presymptomatic or asymptomatic and thus unaware they are infectious.”

This nasal spray treatment could offer real hope to those in the frontline fight against COVID-19, while the treatment offers significant potential to protect the most vulnerable, including those with pre-existing respiratory conditions and the elderly, where vaccines can be less effective.

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