Alumis Initiates ONWARD Phase 3 Clinical Program For ESK-001 In Moderate-To-Severe Plaque Psoriasis; Co-Primary Endpoint PASI 75 And sPGA 0/1 At 24 Weeks To Support U.S. Regulatory Submission; Topline Data Expected In 2026
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Alumis has initiated the ONWARD Phase 3 clinical program for ESK-001, targeting moderate-to-severe plaque psoriasis. The study aims to achieve co-primary endpoints PASI 75 and sPGA 0/1 at 24 weeks to support a U.S. regulatory submission. Topline data is expected in 2026.
July 29, 2024 | 12:03 pm
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Alumis has initiated a Phase 3 clinical trial for ESK-001, targeting moderate-to-severe plaque psoriasis. The trial's success in achieving its co-primary endpoints will be crucial for U.S. regulatory submission, with topline data expected in 2026.
The initiation of a Phase 3 clinical trial is a significant milestone for Alumis. Achieving the co-primary endpoints will be critical for regulatory approval, which could positively impact the stock price. However, the long timeline until 2026 for topline data introduces some uncertainty.
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