Coya Therapeutics hits 100th patient enrollment in Phase 2/3 ALSTARS trial for COYA 302 in ALS

Coya Therapeutics, Inc.

100th patient enrolled in Phase 2/3 ALSTARS trial (NCT07161999) evaluating COYA 302 for ALS as of Sept 15, 2026.
Trial targets 120 total participants; enrollment trending to complete in time for topline data in early Q2 2027.
Study is randomized, double-blind, placebo-controlled, 1:1:1 dosing: two COYA 302 regimens vs placebo over 24 weeks, then 24-week active extension.
Primary endpoint: change in ALSFRS-R total score from baseline to Week 24 vs placebo; also evaluates safety, biomarkers.
COYA 302 combines proprietary low-dose IL-2 and CTLA-4 Ig; FDA Fast Track designation previously granted.

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