Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. REGN announced first data from a descriptive analysis of a seamless phase I/II/III study, evaluating its antibody cocktail candidate, REGN-COV2, in non-hospitalized patients with COVID-19.
Data from the study showed that administration of REGN-COV2 plus usual standard-of-care (SoC) resulted in reduced viral load and the time to alleviate symptoms versus placebo plus SoC. The company stated that patients whose natural immune response was not yet adequate had the greatest treatment benefit, which suggests that REGN-COV2 holds potential as a therapeutic substitute for the naturally-occurring immune response.
Regeneron believes data from this cohort, which evaluated anti-viral activity of a one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of REGN-COV2 (low dose) or placebo, and identified patients most likely to benefit from treatment, to be robust and encouraging. Currently, the study is ongoing and enrolment in the next cohort has been completed. This cohort could be used to rapidly and confirm the reported results.
The company has started discussing these results with regulatory authorities and may file regulatory applications seeking approval for REGN-COV2 as potential treatment for non-hospitalized COVID-19 patients following an outcome from its discussions.
Regeneron’s stock has surged 52.7% in the year so far compared with the industry’s rise of 2.2%.
The company is conducting a phase II/III study to evaluate REGN-COV2 for the treatment of COVID-19 in hospitalized patients. A phase III study is evaluating REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient. The late-stage study is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID).
The candidate is also being evaluated in the phase III study — RECOVERY — sponsored by the University of Oxford. The study is evaluating the candidate in hospitalized patients for impact on hospital stay and the need for ventilation.
The company is one of the leading biotech companies along with Gilead Sciences (NASDAQ:GILD), Inc. GILD working on drugs for the treatment of coronavirus. Another company developing an antibody treatment for COVID-19 is Vir Biotechnology (NASDAQ:VIR) VIR.
Meanwhile, Regeneron recently collaborated with Swiss pharma giant Roche RHHBY (OTC:RHHBY) to develop, manufacture and distribute REGN-COV2, whereby the former will distribute REGN-COV2 in the United States. Regeneron’s efforts to develop REGN-COV2 are impressive and a positive outcome will be a great boost for the company and is much needed, given the widespread outbreak.
Zacks Rank
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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