Phase III trial to study REGN-COV2, potential COVID-19 antibody treatment
REGN-COV2 will be evaluated alongside standard-of-care in a Phase III study as part of the COVID-19 RECOVERY trial.
The University of Oxford, UK, and Regeneron Pharmaceuticals have announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of the world’s largest randomised clinical trials of potential COVID-19 treatments, will evaluate Regeneron’s investigational anti-viral antibody cocktail, REGN-COV2.
The Phase III open-label trial in patients hospitalised with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own. It is anticipated that at least 2,000 patients will be randomly allocated to receive REGN-COV2 plus usual standard-of-care and results will be compared with at least 2,000 patients who receive standard-of-care on its own. Usual standard-of-care varies by local hospital.
Professor Peter Horby at the University of Oxford and chief investigator of the trial, said: “We have already discovered that one treatment, dexamethasone, benefits COVID-19 patients, but the death rate remains too high so we must keep searching for others. The RECOVERY trial was specifically designed so that when promising investigational drugs such as REGN-COV2 became available they can be tested quickly. We are looking forward to seeing whether REGN-COV2 is safe and effective in the context of a large-scale randomised clinical trial; this is the only way to be certain about whether it works as a treatment for COVID-19.”
REGN-COV2 is the first specifically designed COVID-19 therapy being evaluated by RECOVERY. It was selected in part based on its emerging safety profile in humans, pre-clinical data showing it could protect against viral escape mutations and prevention and treatment studies in non-human primates showing it reduced the amount of virus and associated damage in the lungs. REGN-COV2 is currently being studied in two Phase II/III clinical trials for the treatment of COVID-19 and in a Phase III trial for the prevention of COVID-19 in household contacts of infected individuals.
“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 Dr George 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.”
Professor Martin Landray at the University of Oxford, added: “Up to now, we have largely been studying whether existing drugs can be re-purposed to tackle this new disease, but we now have the opportunity to rigorously assess the impact of a drug specifically designed to target this coronavirus. There are good reasons to be excited about this new development – RECOVERY will provide a robust assessment of the effect of this lab-manufactured monoclonal antibody combination treatment in hospitalised patients.”