Coya Therapeutics reaches 100-patient mark in ALS Phase 2/3 trial

Coya Therapeutics, Inc. announced in an 8-K filed September 15, 2026 that the one hundredth patient has been enrolled in its ongoing Phase 2/3 ALSTARS Trial (NCT07161999) evaluating COYA 302, a combination of proprietary low-dose IL-2 and CTLA-4 Ig, for the treatment of amyotrophic lateral sclerosis¹.

Based on current enrollment pace, the company anticipates completing full enrollment of 120 participants in sufficient time to permit reporting topline data in early Q2 of 2027¹.

The ALSTARS Trial is described as a Phase 2/3, randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of COYA 302 in patients with ALS¹. Under the design, approximately 120 subjects will be randomized 1:1:1 to receive one of two pre-specified dosing regimens of COYA 302 or placebo during a 24-week double-blind treatment phase¹.

Following that period, patients who complete the 24-week placebo-controlled phase enter a 24-week blinded active-treatment extension phase; patients receiving COYA 302 continue their assigned regimen, while placebo patients are re-randomized to one of the two COYA 302 dosing regimens, providing up to 48 weeks of data on COYA 302¹.

The trial's primary endpoint is change in disease severity over time, measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score from baseline to Week 24 compared with placebo¹. Additional goals of the study include evaluation of efficacy, safety and tolerability, biological activity, and biomarker levels¹.