Sanofi Says Kevzara Drug Fails To Meet Endpoints in Covid-19 Study
French drugmaker Sanofi announced Tuesday that a late-stage study of the rheumatoid arthritis drug Kevzara tested in severely or critically ill patients hospitalized with COVID-19, failed to meet its main goals.
Sanofi (SNYNF) said that the global Phase 3 trial investigating intravenously administered Kevzara at a dose of 200 mg or 400 mg in hospitalized patients with COVID-19 did not meet its primary endpoint and key secondary endpoint when Kevzara was compared to placebo added to usual hospital care. The 420-patient randomized trial was conducted outside the US in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia and Spain.
“Although this trial did not yield the results we hoped for, we are proud of the work that was achieved by the team to further our understanding of the potential use of Kevzara for the treatment of COVID-19,” said John Reed, Sanofi Global Head of R&D. “In times like these, commitment to properly designed, controlled clinical trials, provides the information and understanding the scientific community needs for fact-based decision making.”
The Phase 3 study showed serious adverse reactions were experienced by 26-29% of Kevzara patients versus 24% of placebo patients. The incidence of adverse events leading to death was approximately 10% in all three treatment arms. Serious infections (including COVID-19 pneumonia) were observed in 11-13% of Kevzara patients and 12% of placebo patients.
At this point, Sanofi and partner Regeneron added that they did not anticipate conducting further clinical studies for Kevzara in COVID-19.
Kevzara is currently approved in multiple countries to treat adults with moderately to severely active rheumatoid arthritis who have not responded to or tolerated previous therapy.
Shares in Sanofi have recovered since reaching a low in March and are now trading about 1.2% higher than at the beginning of the year. (See Sanofi stock analysis on TipRanks)
Last month, Sanofi announced the acquisition of US company Principia Biopharma in an all-stock deal valued at $3.68 billion to help the companies build a portfolio of treatments for autoimmune diseases.
Leerink Partners analyst Geoff Porges reiterated a Hold rating on the stock for now saying that the multiple sclerosis drug that was being co-developed by Principia “adds another real and substantial long term value driver to Sanofi’s growing portfolio” of relatively early-stage research programs.
Meanwhile, TipRanks data shows that the majority of analysts have a bullish outlook on the stock. The Strong Buy consensus boasts 12 Buy ratings versus 2 Hold ratings. The $126.33 average price target reflects 25% upside potential in the shares in the coming 12 months.
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