Bristol Myers-JNJ Partnered Secondary Stroke Drug Misses Endpoint, But Companies See Enough Potential For Phase 3 Trials

Bristol Myers-JNJ Partnered Secondary Stroke Drug Misses Endpoint, But Companies See Enough Potential For Phase 3 Trials
  • Bristol-Myers Squibb Co BMY and Johnson & Johnson's JNJ Janssen announced results from the Phase 2 AXIOMATIC-SSP dose-ranging study of the investigational oral factor XIa (FXIa) inhibitor, milvexian.
  • The data showed that milvexian failed its primary endpoint, a composite endpoint measuring both the dose-response compared with placebo in stroke incidence and a biomarker known as brain infarctions, or lesions that may appear in the absence of a stroke.
  • Also See: Bristol-Myers Squibb Expects Lower FY22 Sales Versus FY21.
  • A relative risk reduction of approximately 30% in symptomatic ischemic stroke with milvexian was observed in patients receiving either 25, 50, or 100 mg twice daily compared to placebo.
  • No fatal bleeding and increased symptomatic intracranial hemorrhage was observed in patients treated with milvexian, even with all patients receiving 21 days of background dual antiplatelet therapy followed by single antiplatelet therapy.
  • The companies look to move forward with Phase 3 of their factor XIa drug in preventing secondary stroke despite missing the goalpost on a composite endpoint.
  • Price Action: BMY shares are down 1.32% at $70.25 during the premarket session on the last check Monday. JNJ stock closed at $164.27 on Friday.

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