Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Sanofi (SNY - Free Report) announced a program to study their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to the coronavirus disease, COVID-19.
A U.S. based phase II/III study has been initiated at medical centers in New York. It will begin enrolling patients immediately. The study, which will enroll up to 400 patients, will test the safety and efficacy of adding Kevzara to usual supportive care, compared to supportive care plus placebo. While Regeneron will lead the U.S. studies, Sanofi will take care of the ex-U.S. studies, which will be initiated in the coming weeks.
Kevzara is an anti-interleukin (IL)-6 receptor monoclonal antibody. In patients who are severely or critically ill with COVID-19, the IL-6 pathway may play an important role in driving the overactive inflammatory response in the lungs, per the press release. The press release mentioned that in a Chinese study, it was observed that another IL-6 receptor antibody (tocilizumab) led to rapidly reduced fevers in critically ill COVID-19 patients.
Also, 75% of patients reduced their need for supplemental oxygen within days of being treated with the medicine. So Regeneron and Sanofi believe that Kevzara due to its IL-6 receptor inhibition may emerge as a treatment option for critically-ill COVID-19 patients,
Kevzara is presently marketed jointly by Sanofi and Regeneron for the treatment of moderately-to-severely active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX). It is being evaluated in phase III studies for giant cell arteritis and polymyalgia rheumatica and in phase II studies in pediatric populations for two indications - polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic
Regeneron’s shares are up 17.4% this year so far against the industry’s decline of 11.8%.
Sanofi’s shares have underperformed the industry this year so far. The stock has declined 17.3% in the said time frame compared with the industry’s decrease of 11%.
Several drug/biotech companies are working on making new antibodies, drugs and vaccines to prevent and treat COVID-19. In addition to the Kevzara studies, Regeneron has an agreement with the U.S. Department of Health and Human Services (HHS) for manufacturing antibodies targeting SARS-CoV-2, the virus that causes COVID-19. Gilead’s (GILD - Free Report) investigational antiviral candidate, remdesivir, is being evaluated in phase III studies to treat COVID-19.
Sanofi has joined forces with BARDA of the U.S. Department of Health and Human Services to quickly develop a vaccine for COVID-19. Sanofi will advance the development of a COVID-19 vaccine by leveraging work on a pre-clinical vaccine candidate for SARS (severe acute respiratory syndrome). COVID-19 and SARS are both coronaviruses that can cause respiratory diseases. Other big drugmakers, J&J and GlaxoSmithKline have also expressed interest in developing a vaccine for COVID-19.
CEPI has provided funding of around $24 million to biotechs like Moderna, Novavax CureVac and Inovio to have potential vaccine candidates in early-stage clinical studies within a few months. In fact, on Monday, Moderna (MRNA - Free Report) announced that the first participant has been dosed in a phase I study of its mRNA vaccine candidate for COVID-19
While Regeneron has a Zacks Rank #1 (Strong Buy), Sanofi has a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank stocks here.
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