Regeneron has asked the US Food and Drug Administration (FDA) for emergency use authorization for its coronavirus antibody treatment.
The submission of the request led to over 4% increase of the company’s stock price in premarket trading.
President Donald Trump took Regeneron’s REGN-COV2 monoclonal antibody coronavirus therapy when he was diagnosed with Covid-19 last week. The president considered Regeneron’s antibody as a “cure” even though there is no existing evidence.
Regeneron issued a statement Wednesday saying that “if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution.”
The therapy is accessible to about 50,000 patients, according to the biotech firm, “and we expect to have doses available for 300,000 patients in total within the next few months.”
REGN-COV2 combines two monoclonal antibodies and was “designed specifically to block infectivity” of the novel coronavirus.
Trump took an 8 gram dose of the antibody cocktail during the initial phase of his infection, despite it having no authorization from the FDA.
According to Regeneron, preclinical studies revealed that REGN-COV2 lessened the amount of virus and associated damage in the lungs of non-human primates. The biotech firm has worked with Roche to boost the global supply of REGN-COV2.
“If REGNCOV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. (beyond the initial U.S. Government supply) and Roche will develop, manufacture and distribute it outside the U.S.,” the company said.
Promising results
Earlier this month, Regeneron has released early data from tests using its antibody cocktail in coronavirus patients.
In some of the early results, Regeneron said the antibody cocktail appears to reduce levels of the coronavirus and improve symptoms among patients. The firm claimed that the biggest improvements were observed in patients who hadn’t already mounted a natural response to the infection.
Dr. Jeanne Marrazzo, the director of the division of infectious diseases at University of Alabama at Birmingham, mentioned that while the results only involve 275 patients of the 1,000 enrolled in this particular trial, they appear “very promising”.
According to Regeneron, the antibody cocktail also showed positive trends at reducing medical visits for the patients, who were not sick enough to be hospitalized at the beginning of the trial.
However, the numbers in this early release of information were small and are yet to be peer-reviewed. The company posted a news release of only the topline data.
A company spokesperson claimed that the initial results validate the treatment as a therapeutic substitute for a natural response to the virus.
Dr. Marrazzo pointed out that what she most noticed was that the study characterized patients by their immune responses prior to treatment and determined who did and did not benefit.
Marrazzo explained: “What I think is fascinating is that it shows that antibodies really matter and the antibody to the spike protein was really helpful, particularly when people made the antibodies themselves.”
“Whether it’s antibody therapy or vaccine that targets these proteins, it sounds like we are on the right track. I think that’s really encouraging,” she added.
