Regeneron’s investigational antibody cocktail will be evaluated in a phase 3 trial coordinated by researchers from Oxford University as a potential treatment for patients hospitalised with COVID-19.
The anti-viral antibody cocktail, REGN-COV2, will be evaluated in the RECOVERY trial in patients hospitalised with COVID-19, with the study set to compare the effects of adding the cocktail to the usual standard-of-care versus standard-of-care treatment alone.
REGN-COV2, which was specifically designed as a COVID-19 therapy, is currently being studied in an additional two phase 2/3 studies for the treatment of the novel disease. Regeneron is also testing the drug in a phase 3 trial for the prevention of COVID-19 in household contacts in infected individuals.
The phase 3 prevention trial is set to be conducted at around 100 sites across the US, and will enrol approximately 2,000 patients with the aim of assessing SARS-CoV-2 infection status. Meanwhile, 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 pre-clinical 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 demonstrated that the cocktail could reduce the amount of virus and associated damage in the lungs.
The drug’s ability to protect against viral escape is particularly noteworthy, as this process occurs when spontaneously arising mutant forms of a virus are able to evade a therapeutic’s blocking action, when that virus is under pressure from said anti-viral therapeutic.
This means that REGN-COV2 could protect against mutant forms of the SARS-CoV-2 virus, which cause COVID-19, that are often able to survive and proliferate and can ultimately become the dominant strain of the virus.
“The world urgently needs new medicines to combat COVID-19, and well-designed trials to evaluate new treatment options will quickly help us learn which are most effective,” said George D Yancopoulos, president and chief scientific officer of Regeneron.
“REGN-COV2 was specifically designed by Regeneron scientists to target the virus that causes COVID-19. RECOVERY will be the fourth late-stage randomised clinical trial evaluating REGN-COV2 and will add to our knowledge about how this novel antibody cocktail may help hospitalised patients in need,” he added.
In August, Regeneron signed a deal with Roche to bolster manufacturing and global development capabilities for REGN-COV2. 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 deal, Roche and Regeneron are jointly funding and executing the ongoing phase 3 prevention trial, as well as further phase 1 safety studies.