Coya Therapeutics reported on September 15, 2026, that the 100th patient has been enrolled in ALSTARS, its Phase 2/3 trial of COYA 302 for amyotrophic lateral sclerosis. That number matters for a specific reason: ALS trials routinely struggle to recruit, and hitting triple digits is the point at which enrollment momentum typically becomes readable enough to project a completion date with some confidence. Coya says current trends support a full enrollment forecast, though the filing does not name a specific target date.
COYA 302 pairs low-dose IL-2 with CTLA-4 Ig, a combination designed to expand regulatory T cells and dampen the neuroinflammatory activity implicated in ALS motor neuron loss. The double-blind, placebo-controlled ALSTARS trial (NCT07161999) is testing that mechanism in a multi-center setting, with functional decline and safety as central measures. The immune angle is notable because riluzole and edaravone, the mainstays of ALS management, target glutamate toxicity and oxidative stress, leaving neuroinflammation largely unaddressed by approved therapies.
The enrollment milestone also arrives at a moment when the ALS treatment field has fewer options than it did two years ago. Relyvrio, approved in September 2022, was withdrawn from the market by Amylyx in early 2024 after a confirmatory trial failed, narrowing the field back to its older standards. That contraction sharpens attention on mechanistically distinct approaches like COYA 302, without guaranteeing anything about efficacy outcomes.
The number to watch from here is not enrollment itself but the pace at which Coya translates current trends into a declared completion date. A public enrollment target would let observers assess how much runway the trial has before a primary readout becomes schedulable, and whether the company’s financing is sized to cover it.
Source link: https://www.sec.gov/Archives/edgar/data/1835022/000119312526391378/d896544d8k.htm
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
