Servier reported that sevasemten failed to slow disease progression in the placebo-controlled Phase 3 GRAND CANYON study. The negative outcome diverged sharply from earlier randomized clinical data that had shown promise for the candidate. Servier originally acquired the drug in June for $1.55 billion in upfront cash, with up to roughly $1 billion more tied to future milestones. The drugmaker is currently evaluating the complete trial dataset alongside historical research to understand why the pivotal findings contradicted earlier tests.
Key points
The candidate failed to slow the progression of Becker muscular dystrophy during its majo…: The candidate failed to slow the progression of Becker muscular dystrophy during its major placebo-controlled clinical trial.
Patients diagnosed with Becker muscular dystrophy continue to face a complete absence of…: Patients diagnosed with Becker muscular dystrophy continue to face a complete absence of approved therapeutic treatments.
Servier is currently conducting a comprehensive review of the entire trial dataset to inv…: Servier is currently conducting a comprehensive review of the entire trial dataset to investigate why the results diverged from earlier studies.
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The French pharma Servier said Tuesday that an experimental drug it purchased in June for $1.55 billion in cash, plus about $1 billion more in potential milestones, failed to slow a rare form of muscular dystrophy in a long placebo-controlled trial.
It’s a surprising setback for both Servier and for patients with Becker muscular dystrophy, who currently have no approved treatments. The drug, called sevasemten and originally developed by Edgewise Therapeutics, had previously shown promising results in a smaller, randomized study.
“The results of the pivotal GRAND CANYON study are not aligned with certain findings observed in prior clinical studies,” Servier said in a statement, using the company’s name for the Phase 3 trial. “Servier is conducting a comprehensive analysis of the GRAND CANYON study dataset, together with relevant prior clinical data, to better understand and further characterize the study findings.”
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