Developing new drugs tends to be a rollercoaster ride.
A disappointing set of data from Regeneron Pharmaceuticals Inc. and Sanofi’s mid-stage clinical trial testing rheumatoid arthritis drug Kevzara as a COVID-19 treatment underscores the traditional ups and downs of drug development that have now been heightened by the global pandemic.Kevzara was first proposed as a potential treatment after researchers in China published data from a single-arm trial with 21 patients that found Roche Holding AG’s ROG, +0.
There are no proven treatments or vaccines for the novel coronavirus at this time. More than three million people have tested positive for the virus, and at least 212,000 have died, according to aggregated data from Johns Hopkins University. On Monday, they said that going forward they would limit the Phase 3 trial to only include patients defined as critical, which includes those requiring mechanical ventilation, high-flow oxygenation, or being cared for in an intensive care unit, given that sicker patients seemed to show some improvement while taking the drug. The next phase of the study will also only include a higher dose of the drug and the placebo, and not the lower dose of 200 milligrams used in the mid-stage trial.
“Although this might come as a relative disappointment to some — especially given the heightened sensitivities around COVID-19 — we believe REGN may have a better shot treating this pandemic with its antibody cocktail,” J.P. Morgan analysts wrote Monday night. “All in, today’s updates are not thesis changing.”
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