Coya Therapeutics FDA requires additional non-clinical data before initiating Phase 2 ALS trial for COYA 302

Coya Therapeutics, Inc.

Submitted IND for Phase 2 double-blind, placebo-controlled study of COYA 302 in ALS on June 14, 2024.
FDA notified on July 12, 2024 that additional non-clinical data is required prior to study initiation.
FDA will provide details on required data within 30 days.
Study was designed as 24-week treatment phase with 24-week open-label extension.
Regulatory delay may push back clinical timeline for COYA 302.

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