COYA 302 - (ALSTARS)

September 15, 2026: Coya Therapeutics (NASDAQ: COYA) announced the 100th patient has been enrolled in the Phase 2/3 ALSTARS trial (NCT07161999) of COYA 302 for amyotrophic lateral sclerosis (ALS). Based on current screening and enrollment rates, the company expects to complete enrollment of about 120 patients in the coming weeks and report topline data in early Q2 2027.

ALSTARS is a randomized, multi-center, double-blind, placebo-controlled study with a 24-week double-blind treatment phase and a 24-week blinded active-treatment extension; additional participants are continuing to roll over into the extension arm. Patients are randomized 1:1:1 to one of two COYA 302 dosing regimens or placebo. The primary endpoint is change in ALS disease severity over time as measured by ALSFRS-R total score from baseline to Week 24 versus placebo. Objectives also include safety, tolerability, biological activity, and biomarkers.

COYA 302 is a proprietary combination of low-dose IL-2 and CTLA-4 Ig intended to enhance regulatory T-cell function and suppress inflammation. The release also states COYA 302 has received FDA Fast Track designation for ALS and remains investigational, with no FDA approval.