Sanofi, Regeneron shut down Kevzara trial in COVID-19 after finding no benefit for ventilated patients

In the early days of the COVID-19 pandemic, Sanofi and Regeneron launched an ambitious plan to try out rheumatoid arthritis med Kevzara in desperately ill patients. But after early warning signs, a phase 3 flop has forced the drugmakers to can their U.S. trial.

Sanofi and Regeneron have stopped their stateside study of Kevzara in mechanically ventilated COVID-19 patients after the drug failed to prevent deaths or get patients off ventilation, among other key endpoints, the drugmakers said Thursday. 

Kevzara, added to standard-of-care therapy, not only failed to better patients’ condition after 22 days, but the drug’s “minor positive trends” in ventilated patients were also offset by poor results in a partially enrolled subgroup that had not been ventilated at the start of treatment, the companies said.

Moreover, 80% of patients treated with the 400-milligram dose of Kevzara showed side effects compared with 77% in the standard-of-care control arm. Severe side effects, including multi-organ dysfunction and low blood pressure, were observed in 3% of Kevzara patients. 

Sanofi and Regeneron said they plan to publish the full results of the study in a peer-reviewed journal.

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The failure follows bad news from April, when the drugmakers said they would scale back study enrollment in the U.S. after a phase 2 precursor showed negligible results in treating “severe” COVID-19 patients requiring oxygen therapy, but not more intensive treatment. The phase 3 trial also stripped out a 200-mg dose of Kevzara, which showed little efficacy at the phase 2 stage. 

With the U.S. trial closed, a non-U.S. Kevzara study will march on despite the warning signs, with results likely coming in the third quarter, the drugmakers said. 

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