Coya Therapeutics completes enrollment of 120 patients in Phase 2/3 ALSTARS trial of COYA 302 in ALS

Coya Therapeutics, Inc.

Full enrollment reached at 120 patients in the Phase 2/3 ALSTARS Trial (NCT07161999) evaluating COYA 302 for ALS; additional eligible screening patients may still enroll.
Topline data from the 24-week double-blind treatment phase are anticipated in early Q2 2027.
Trial randomizes ~120 subjects 1:1:1 to one of two dosing regimens of COYA 302 (low-dose IL-2 plus CTLA-4 Ig) or placebo.
Primary endpoint is change in ALSFRS-R total score from baseline to Week 24 vs placebo; also assesses safety, biological activity and biomarkers.
Completers enter a 24-week blinded active-treatment extension, with placebo patients re-randomized to COYA 302, yielding up to 48 weeks of COYA 302 data.

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