Coya Therapeutics Announces 100th Patient Enrolled in Phase 2/3 ALSTARS Trial

What Happened
On September 15, 2026, Coya Therapeutics, Inc. (COYA) announced via an 8-K that the 100th patient has been enrolled in its ongoing Phase 2/3 ALSTARS Trial (NCT07161999) testing COYA 302 (a combination of low‑dose IL‑2 and CTLA‑4 Ig) for amyotrophic lateral sclerosis (ALS). The company said current enrollment trends support completing full enrollment of 120 participants in time to permit reporting topline data in early Q2 2027.

Key Details

• Trial: Phase 2/3 ALSTARS (NCT07161999), randomized, multi-center, double‑blind, placebo‑controlled.
• Enrollment: 100 patients enrolled as of Sept 15, 2026; target enrollment is 120.
• Design: ~120 subjects randomized 1:1:1 to two pre-specified COYA 302 dosing regimens or placebo for a 24‑week double‑blind phase, followed by a 24‑week blinded active‑treatment extension (up to 48 weeks of COYA 302 data).
• Primary endpoint: Change in disease severity measured by ALSFRS‑R total score from baseline to Week 24 versus placebo.
• Other: Filing includes standard forward‑looking statement caution and references potential benefits tied to the FDA Fast Track designation for COYA 302.

Why It Matters
This update reflects meaningful progress in patient enrollment for a late‑stage ALS study of COYA 302; reaching full enrollment and the planned timeline for topline data (early Q2 2027) are key near‑term milestones for investors tracking clinical progress and potential regulatory value. The filing is primarily operational and does not provide efficacy or safety results—investors should look for the upcoming topline readout and related disclosures for outcome data.