In the early days of the COVID-19 pandemic, Sanofi and Regeneron launched an ambitious plan to test rheumatoid arthritis with Kevzara in desperately ill patients. But after the first warning signs, a phase 3 failure has forced drug makers to make their judgment in the United States.
Sanofi and Regeneron have suspended their U.S. study of Kevzara in mechanically ventilated COVID-19 patients after the drug was unable to prevent deaths or leave patients unventilated, among other key endpoints, the makers of medicines.
Kevzara, added to standard care therapy, not only did not improve 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 He had not been ventilated at the start of treatment, the companies said.
Additionally, 80% of patients treated with the 400 milligram dose of Kevzara showed side effects compared to 77% in the standard care control arm. Serious side effects, such as multiple 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 the bad news from April, when drug makers said they would cut study enrollment in the US after a phase 2 precursor showed insignificant results in treating “serious” patients with COVID- 19 requiring oxygen therapy, but not more intensive treatment. The phase 3 trial also removed a 200 mg dose of Kevzara, which showed little efficacy in the phase 2 stage.
With the US trial closed, a study of non-US Kevzara will move forward despite warning signs, with results likely in the third quarter, drug makers said.
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In late March, Sanofi and Regeneron dosed the first patient in the US arm of their phase 2/3 Kevzara study, which hoped to enroll 300 patients at sites in Italy, Spain, Germany, France, Canada, and Russia. .
The partners launched their global Kevzara program after a small-scale, single-arm study in China showed the drug could hold promise in ventilated patients.
Meanwhile, another circulating IL-6 inhibitor, Roche’s Actemra, has also published less than stellar results in patients with COVID-19.
In June, a study licensed by Italy’s drug regulator Aifa found that Actemra did not improve patients’ severe respiratory symptoms, reduce ICU visits, or reduce death rates better than standard care. Aifa said the study was the first worldwide randomized trial for Actemra at COVID-19. The study should be considered “important and conclusive” in early-stage COVID-19 pneumonia, Aifa said.
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As Kevzara is increasingly seen as a failure, Sanofi and Regeneron will likely lean on their second archery with an antibody cocktail that went into a Phase 3 preventive test on Monday.
The late-stage study, a joint effort with the National Institute of Allergy and Infectious Diseases, will enroll 2,000 American patients at approximately 100 clinical sites, the drug makers said. The companies will study the effects of the antibody cocktail on decreasing COVID-19 infection rates.
Meanwhile, Sanofi and Regeneron are also taking their antibody conjugate in two phase 2/3 trials to treat hospitalized and non-hospitalized COVID-19 patients in the US, Brazil, Mexico, and Chile. The results of those studies are expected in late summer, the companies said.
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