Sanofi, today, announced that the global Phase 3 trial investigating intravenously administered Kevzara® (sarilumab) at a dose of 200 mg or 400 mg[a] in severely or critically ill patients hospitalized 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 (86 in placebo, 161 in 200 mg, and 173 in 400 mg arms).
“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, M.D., Ph.D., Global Head of Research and Development, Sanofi.
“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. At Sanofi, we are committed to help combat the global COVID-19 pandemic, including developing vaccine candidates that can be manufactured at large-scale.”
Although not statistically significant, numerical trends were observed toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes, as measured by a 2-point improvement from baseline on the 7-point scale.
Further, a trend was observed towards reduced mortality in the critical patient group which was not seen in the severe patient group. Finally, the time to discharge was shortened by 2-3 days (statistically non-significant) in the patients treated with Kevzara within the first two weeks of treatment.
Serious adverse events were experienced by 26-29% of Kevzara patients and 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.
Detailed results will be submitted to a peer-reviewed publication later this year. At this time, Sanofi and Regeneron do not anticipate conducting further clinical studies for Kevzara in COVID-19.
About Kevzara® (sarilumab) Injection
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.
Kevzara binds specifically to the IL-6 receptor and has been shown to inhibit IL-6 mediated signalling. IL-6 is an immune system protein produced in increased quantities in patients with rheumatoid arthritis and has been associated with disease activity, joint destruction and other systemic problems.
HEADLINES YOU MIGHT HAVE MISSED FROM BRAND SPUR
CredoLab raises USD 7m to expand its market reach in Africa and other new markets
CredoLab, a leading developer of bank-grade digital credit scorecards based on smartphone metadata which launched in Nigeria, Kenya, and South Africa, last year, has secured USD 7 million in its Series-A round funding led by GBG, the global specialist in identity data intelligence.
Cars with embedded connectivity to reach 200m by 2025, with 5G adoption set to soar
A new study from Juniper Research has found that the number of cars with embedded connectivity will reach 200 million globally by 2025; rising from 110 million in 2020. One of the main beneficiaries of this growth will be mobile
Nitro121 promises bespoke offerings to clients, celebrates 15th anniversary
The leading brand-building and marketing communication company, Nitro 121 (formerly known as 141 Worldwide), turns fifteen on the 1st of September 2020 and promises to continue to deliver bespoke marketing communications services to clients and other partners.
Top 25 most valuable aerospace and defence brands could lose over $22bn of brand value from COVID-19
Aerospace and defence sector heavily impacted by COVID-19 pandemic, brands could lose up to 20% of brand value, equating to a US$22.8 billion loss cumulatively
