Coya Therapeutics plans open-label extension of ALS trial, pushes back FTD study start

Coya Therapeutics disclosed in an 8-K filing dated October 14, 2026 that it plans to initiate an open-label extension of its Phase 2/3 ALSTARS Trial (NCT07161999), which is evaluating COYA 302 for amyotrophic lateral sclerosis.¹ The company said the extension responds to requests from ALSTARS investigators and study participants.¹

Under the extension plan, participants who finish the 48-week treatment period will be able to keep receiving COYA 302, and the trial will continue gathering longer-term data on efficacy and safety.¹ Coya said it expects the extension to start in November 2026, once the first patient cohort completes the 48-week treatment period.¹

The company tied this plan to a shift in resources. It said it intends to focus on the ongoing ALS development work for COYA 302 and on hitting near-term milestones in the ALSTARS Trial.¹ As a result, a separate Phase 2 trial of COYA 302 in frontotemporal dementia, originally expected to start in the second half of 2026, is now expected to begin in 2027.¹

Coya said its financial outlook has not changed: current cash is expected to support operations into the second half of 2027, past the point when ALSTARS topline data are expected.¹

The ALSTARS study itself is described as a Phase 2/3, randomized, multi-center, double-blind, placebo-controlled trial testing COYA 302 in ALS patients, enrolling about 120 subjects split evenly across two COYA 302 dosing regimens and placebo over a 24-week double-blind period.¹ Those who finish that stage move into a second 24-week stage in which patients originally on COYA 302 stay on their regimen while placebo patients are reassigned to one of the two active dosing groups, generating up to 48 weeks of COYA 302 exposure data.¹ The filing states that the primary endpoint is the change in ALSFRS-R score from baseline to Week 24 versus placebo.¹