Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) announced on Monday that a late-stage study evaluating Kevzara as a treatment for COVID-19 will be changed to only enroll COVID-19 patients in critical condition and only use a higher dose of the drug. The study previously included patients with severe cases of COVID-19 who weren't in critical condition and was testing two doses of Kevzara -- 200 milligrams and 400 milligrams.
Why the changes were made
The decision to make those changes came after the study's independent data monitoring committee (IDMC) reviewed data from the phase 2 part of the study along with preliminary data available from the phase 3 portion. The IDMC determined that Kevzara provided no clinical benefit compared to placebo for patients with severe cases of COVID-19.
However, patients in critical condition appeared to have more positive outcomes after taking Kevzara. The data also showed that patients who were administered the higher 400 mg dose of the drug appeared to achieve better outcomes than those on the lower dose.
Regeneron and Sanofi are continuing to enroll patients in the ongoing phase 3 portion of the study, which already includes more than 600 patients in critical condition. The companies expect to announce results from the study by June.
Another late-stage study of Kevzara is also being conducted internationally, with enrollment of patients underway in Canada, France, Germany, Israel, Japan, Russia, and Spain. Regeneron and Sanofi anticipate reporting results from this second study in the third quarter.