Sanofi SNY announced that the phase III study evaluating its rheumatoid arthritis (RA) drug, Kevzara (sarilumab), in severely or critically ill patients hospitalized with COVID-19 did not meet the primary endpoint and key secondary endpoint. The study was conducted by Sanofi outside the United States in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia and Spain and enrolled about 420 patients.
The study tested the safety and efficacy of Kevzara compared to placebo added to usual hospital care.
Data from the study showed that treatment with Kevzara achieved decreasing numerical trends in the duration of hospital stay as well as an acceleration in time to improve clinical outcomes but failed to achieve statistical significance. Moreover, Kevzara also led to positive trends in reducing mortality in the critical patient group, which was not observed in the severe patient group.
Serious adverse events were experienced by 26%-29% of Kevzara patients and 24% of placebo patients. Serious infections, including COVID-19-related pneumonia, were observed in 11-13% of patients treated with Kevzara versus 12% in the placebo arm.
Shares of Sanofi have increased 0.7% year to date compared with the industry’s growth of 1.5%.
In July, a Sanofi-led U.S.-based phase III study evaluating Kevzara in critical COVID-19 patients also failed to meet the primary and key secondary endpoints. The study also showed minor positive trends in critical patients whenKevzara 400 mg was added to the best supportive care and they did not reach a statistical significance. In the primary analysis group, adverse events were experienced by 80% of Kevzara patients and 77% of placebo patients. Based on these results the U.S.-based study was stopped.
Kevzara is presently marketed jointly by Sanofi and Regeneron REGN 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.
Several drug/biotech companies are working on making new antibodies, drugs and vaccines to prevent and treat COVID-19. Gilead’s GILD investigational antiviral candidate, remdesivir, is being evaluated in phase III studies to treat COVID-19. In May 2020, the FDA issued an emergency use authorization for remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
However, another company Roche Holding AG’s RHHBY study on immunology drug, Actemra, for COVID-19 has failed.
Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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