COYA 302 - (ALSTARS)

October 5, 2026: Coya Therapeutics (NASDAQ: COYA) announced full enrollment of the planned 120 participants in the Phase 2/3 ALSTARS trial (NCT07161999) of COYA 302 for amyotrophic lateral sclerosis (ALS). Additional patients already in active screening may still enroll if eligible.

ALSTARS is a randomized, multicenter, double-blind, placebo-controlled study testing two dosing regimens of COYA 302 versus placebo over a 24-week double-blind phase, followed by a 24-week blinded active-treatment extension. The primary endpoint is change from baseline to Week 24 in ALS Functional Rating Scale-Revised (ALSFRS-R) total score versus placebo. The study also assesses safety, tolerability, biological activity, and biomarkers.

Topline data from the 24-week double-blind treatment phase remain on track for early Q2 2027.

COYA 302 is a proprietary combination of low-dose IL-2 and CTLA-4 Ig intended to enhance regulatory T-cell function; it has received FDA Fast Track designation for ALS and is not yet approved. The release also notes Coya’s December 2023 exclusive collaboration with Dr. Reddy’s Laboratories, under which Dr. Reddy’s holds global ALS commercialization rights except in Japan, South America, and Mexico, while Coya leads U.S. clinical development and regulatory efforts.