Coya Therapeutics: announces full enrollment of 120 patients in ALSTARS trial

What happened

• Coya Therapeutics announced on Oct 5, 2026 that it had achieved full enrollment of the planned 120 patients in its ongoing Phase 2/3 ALSTARS Trial (NCT07161999) evaluating COYA 302, the company’s combination of proprietary low-dose IL-2 and CTLA-4 Ig, for the treatment of amyotrophic lateral sclerosis.
• The filing says additional participants already engaged in active screening will be allowed to enroll if deemed eligible. Topline data from the double-blind treatment phase are anticipated in early Q2 2027.

Key details

• Trial design: Phase 2/3, randomized, multi-center, double-blind, placebo-controlled.
• Randomization: Approximately 120 subjects randomized 1:1:1 to one of two pre-specified dosing regimens of COYA 302 or placebo during a 24-week double-blind treatment phase.
• Extension and data: Patients who complete the 24-week placebo-controlled phase enter a 24-week blinded active-treatment extension; placebo patients are re-randomized to one of the two COYA 302 dosing regimens, providing up to 48 weeks of data.
• Primary endpoint: 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 placebo.

Why it may matter

• The filing reports Item 8.01 Other events and includes a press release announcing full enrollment, trial details, the anticipated timing of topline data, and customary forward-looking statements about development timelines, potential benefits, and risks. The filing does not show why the insider traded or why the company acted.