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July 3, 2020updated 12 Jul 2022 11:44am

Sanofi and Regeneron’s Kevzara fails in Phase III Covid-19 trial

Sanofi and Regeneron Pharmaceuticals have reported that a Phase III clinical trial of rheumatoid arthritis drug Kevzara (sarilumab) failed to meet its primary and key secondary endpoints in Covid-19 patients who required mechanical ventilation in the US.

Sanofi and Regeneron Pharmaceuticals have reported that a Phase III clinical trial of rheumatoid arthritis drug Kevzara (sarilumab) failed to meet its primary and key secondary endpoints in Covid-19 patients who required mechanical ventilation in the US.

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The study compared 400mg dose of the drug plus best supportive care to best supportive care alone.

Minor positive trends were demonstrated in the primary pre-specified analysis group but did not achieve statistical significance. Also, these trends were countered by negative trends in a subgroup of critical patients who were not on mechanical ventilation at baseline.

In the primary analysis arm, adverse events were reported in 80% of patients treated with Kevzara and 77% of those on placebo.

Serious adverse events in at least 3% of patients, more frequent among Kevzara patients, were multi-organ dysfunction syndrome and hypotension.

Based on the data, the companies have halted this US-based trial, including a second cohort of patients who were on a higher 800mg dose of the drug.

The primary analysis involved 194 patients who were critically ill and were on mechanical ventilation at the time of enrolment.

Sanofi and Regeneron designed the Phase III trial based on findings from a small, single-arm study in China involving mostly severe, febrile, hospitalised Covid-19 patients with elevated IL-6 levels.

The study findings indicated that blocking this pathway with the IL-6 blocker tocilizumab rapidly decreased fever and improved oxygenation in severe patients.

In addition to this Kevzara trial, Sanofi is conducting a Phase III study outside of the US in hospitalised patients with severe and critical Covid-19 using a different dosing regimen.

Both the trials are overseen by the same Independent Data Monitoring Committee (IDMC), which recommended that the trial being conducted outside of the US can continue.

Data from the trial outside of the US is expected in the third quarter of this year.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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