Regeneron and Sanofi have amended the clinical trial to continue enrolling only critical patients to receive Kevzara 400mg or placebo
Regeneron and Sanofi unveil US Phase 2/3 trial of Kevzara in COVID-19 patients. (Credit: valelopardo from Pixabay.)
Regeneron Pharmaceuticals and Sanofi have unveiled preliminary results from the Phase 2 portion of an ongoing Phase 2/3 clinical trial of Kevzara (sarilumab) in hospitalized patients with critical or severe respiratory illness caused by COVID-19.
The clinical trial has been amended to continue enrolling only critical patients to receive Kevzara 400mg or placebo, following a review by the Independent Data Monitoring Committee (IDMC) of the available Phase 2 and Phase 3 data.
Regeneron co-founder and president George D Yancopoulos said: “Even in a pandemic setting, it’s both crucial and possible to obtain controlled data in adequately-sized trials to provide the evidence needed to inform optimal medical care.
“Emerging evidence with Kevzara and other repurposed drugs in the COVID-19 crisis highlight the challenges of making decisions about existing medicines for new viral threats using small, uncontrolled studies.
“We await results of the ongoing Phase 3 trial to learn more about COVID-19 and better understand whether some patients may benefit from Kevzara treatment.
“In addition, there is an acute need for tailored approaches that specifically target this virus. To that end, Regeneron is rapidly advancing our targeted anti-SARS-CoV-2 antibody cocktail and we plan to initiate clinical trials in June.”
Kevzara has reduced the C-reactive protein (CRP) in the Phase 2 clinical trial
The Phase 2 portion of the trial compared intravenously-administered Kevzara higher dose (400 mg), Kevzara lower dose (200 mg) and placebo.
The study evaluated 457 hospitalized patients, who were categorized at baseline as a severe illness if they required oxygen supplementation without mechanical oxygenation, or critical illness if they require mechanical ventilation, or multi-system organ dysfunction (MSOD).
The preliminary analysis of Phase 2 clinical trial showed that Kevzara has reduced the C-reactive protein (CRP), a key marker of inflammation, and met the primary endpoint.
All treatment arms in the study showed elevated baseline levels of IL-6, with higher levels observed in critical patients compared to severe patients. No new safety signals were observed with the use of Kevzara in COVID-19 patients.
Sanofi global R&D head John Reed said: “As we quickly follow the science to better understand this disease and explore how to best treat patients, these initial results from the randomized clinical trial setting provide physicians much-needed insights and information regarding the potential of Kevzara for patients with COVID-19 treatment.
“While our evaluation of the use of Kevzara for COVID-19 treatment remains an investigational approach, Sanofi continues to stay at the forefront of multiple initiatives to fight this disease, including researching other potential treatment options, developing vaccine candidates that can be manufactured at large-scale, and a potential collaboration for an innovative SARS-CoV-2 smartphone-based self-testing solution.”