[ad_1]
Regeneron’s investigational antibody cocktail will be evaluated in a phase 3 trial coordinated by researchers at the University of Oxford as a potential treatment for hospitalized COVID-19 patients.
The antiviral antibody cocktail, REGN-COV2, will be evaluated in the RECOVERY trial in hospitalized patients with COVID-19, with the study set up to compare the effects of adding the cocktail to the standard of care versus the standard of treatment. -Cospital treatment alone.
REGN-COV2, which was specifically designed as a COVID-19 therapy, is currently being studied in two additional phase 2/3 studies for the treatment of the new disease. Regeneron is also testing the drug in a phase 3 trial for the prevention of COVID-19 in household contacts of infected people.
The phase 3 prevention trial will be conducted at about 100 sites in the US and will enroll approximately 2,000 patients with the goal of assessing their SARS-CoV-2 infection status. In the meantime, the two phase 2/3 treatment trials are planned to be conducted at approximately 150 sites in the US, Brazil, Mexico, and Chile, and will evaluate virologic and clinical endpoints.
In preclinical studies, the antibody cocktail was able to protect against viral escape mutations associated with COVID-19, and prevention and treatment studies in non-human primates also showed that the cocktail could reduce the amount of virus and associated damage in the lungs. . .
The ability of the drug to protect against viral escape is particularly remarkable, since this process occurs when mutant forms of a virus that arise spontaneously are capable of evading the blocking action of a therapy, when that virus is under pressure from such therapy antiviral.
This means that REGN-COV2 could protect against mutant forms of the SARS-CoV-2 virus, which cause COVID-19, which can often survive and proliferate, and can ultimately become the dominant strain of the virus.
“The world urgently needs new drugs to combat COVID-19, and well-designed trials to evaluate new treatment options will quickly help us learn which ones are most effective,” said George D Yancopoulos, Regeneron’s President and Chief Scientific Officer.
“REGN-COV2 was specifically designed by Regeneron scientists to target the virus that causes COVID-19. RECOVERY will be the fourth late-stage randomized clinical trial to evaluate REGN-COV2 and will add to our understanding of how this new antibody cocktail can help hospitalized patients in need, “he added.
In August, Regeneron signed an agreement with Roche to strengthen REGN-COV2’s global development and manufacturing capabilities. Under the terms of this agreement, Regeneron will distribute and record sales of the antibody cocktail in the US, while Roche will be responsible for distribution outside of the US.
The collaboration is expected to increase the supply of REGN-COV2 by at least three and a half times its current capacity, according to Roche. As part of the agreement, Roche and Regeneron are jointly funding and executing the ongoing phase 3 prevention trial, as well as other phase 1 safety studies.
