Regeneron Pharmaceuticals, Inc. REGN and the University of Oxford announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY) will evaluate the former’s investigational anti-viral antibody cocktail, REGN-COV2.
REGN-COV2 comprises two monoclonal antibodies (REGN10933 and REGN10987).
RECOVERY is one of the world’s largest studies to find effective COVID-19 treatments. The trial is being coordinated by researchers at the University of Oxford, which acts as the sponsor for the research.
REGN-COV2 is the first specifically designed COVID-19 therapy being evaluated by RECOVERY. The open-label phase III study will assess the impact of adding REGN-COV2 to the usual standard-of-care versus only standard-of-care. Both safety and efficacy of the candidate will be tested.
Other endpoints include the impact on hospital stay and the need for ventilation. Approximately 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 alone.
The trial has already identified one treatment, dexamethasone, which benefits COVID-19 patients, but the death rate remains too high. Hence, efforts are being made to evaluate other potential treatments for the same.
We remind investors that REGN-COV2 is currently being studied in two phase II/III studies for the treatment of COVID-19 and in a phase III study for the prevention of COVID-19 in household contacts of infected individuals. This makes RECOVERY the fourth late-stage randomized clinical study evaluating REGN-COV2.
Meanwhile, in June, the RECOVERY study also included convalescent plasma for evaluation to treat COVID-19 patients.
REGN-COV2’s development and manufacturing have been funded in part by the Biomedical Advanced Research and Development Authority (BARDA).
Regeneron has also collaborated with Roche RHHBY to increase the global supply of REGN-COV2.
Regeneron’s stock has surged 50.2% in the year so far compared with the industry’s gain of 1.3%.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is running a race against time to come up with treatments and vaccines to cure the contagion. Given the alarming levels of the spread and severity of the pandemic, quite a few biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients.
Gilead Sciences GILD recently announced that the FDA has expanded the Emergency Use Authorization (EUA) for its investigational antiviral, Veklury (remdesivir), for the COVID-19 infection. Veklury can now be used to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.
Eli Lilly and Company LLY has also initiated BLAZE-2, a phase III study evaluating LY-CoV555 for the prevention of SARS-CoV-2 infection. LY-CoV555, the lead antibody from Lilly’s collaboration with AbCellera, is a neutralizing antibody against SARS-CoV-2.
Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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