Coya to Launch COYA 302 Extension Study in ALS in November

HOUSTON, October 14, 2026

Open-Label Extension to Expand Long-Term Data Collection

The planned OLE will offer eligible participants who complete the 48-week ALSTARS treatment period the opportunity to continue receiving COYA 302. The extension is intended to provide longer-term information about the candidate’s safety, tolerability and potential treatment effects in people living with ALS. Coya expects the first cohort to complete the initial treatment period in time for the extension to begin in November 2026. Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya Therapeutics, said interest from investigators and participants highlighted the importance of providing continued treatment access to eligible individuals. He noted that the extension would offer an opportunity to further characterize COYA 302 during longer-term treatment. The company also acknowledged the contributions of patients, families and investigators participating in the study. An open-label extension differs from the placebo-controlled portion of a clinical trial because participants and investigators know that the investigational treatment is being administered. Consequently, the extension can contribute additional safety and treatment-exposure information, but it does not provide the same controlled comparison as a blinded, placebo-controlled phase. The OLE will build on the data collected in the ongoing ALSTARS trial and may help inform the continued clinical development of COYA 302. The candidate remains investigational and has not been approved by the U.S. Food and Drug Administration (FDA) or another regulatory agency.

ALSTARS Trial Evaluates COYA 302 in ALS

The Phase 2/3 ALSTARS trial is a randomized, multicenter, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of COYA 302 in approximately 120 participants with ALS. Participants are randomized in a 1:1:1 ratio to receive one of two prespecified COYA 302 dosing regimens or placebo during a 24-week double-blind treatment phase. Participants completing that phase enter a further 24-week blinded active-treatment extension. Those already receiving COYA 302 continue their assigned regimen, while participants initially assigned to placebo are re-randomized to one of the two active-treatment regimens. This design provides up to 48 weeks of COYA 302 treatment data. The trial’s primary endpoint is the change in disease severity from baseline to Week 24, measured using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score compared with placebo. Additional objectives include evaluating safety, tolerability, biological activity and biomarkers. The new OLE is intended to allow eligible participants to continue treatment beyond the original 48-week period. ALS is a progressive neurodegenerative disease affecting motor neurons in the brain and spinal cord, impairing voluntary muscle functions such as speaking, swallowing and breathing. Although approved therapies are available, the disease continues to carry substantial unmet medical need. Results from the controlled ALSTARS study will be important in assessing whether COYA 302 provides meaningful clinical benefit.

Development Priorities and Financial Outlook

Coya said it will prioritize resources toward the ongoing development of COYA 302 for ALS and the timely completion of near-term ALSTARS milestones. As part of this strategy, the planned Phase 2 trial in frontotemporal dementia has been deferred from the second half of 2026 to 2027. Chief Financial Officer David Snyder said the company considers prioritizing COYA 302 in ALS an appropriate near-term financial and operational strategy. Coya’s cash runway guidance remains unchanged, with existing cash resources expected to support operations into the second half of 2027. This period extends beyond the company’s anticipated early Q2 2027 ALSTARS topline data readout, according to the announcement. COYA 302 is a proprietary investigational biologic combination comprising low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig, intended for subcutaneous administration. Its dual immunomodulatory approach is designed to enhance the anti-inflammatory function of regulatory T cells while suppressing inflammation produced by activated monocytes and macrophages. The company believes these mechanisms may have additive or synergistic effects, although this remains to be established through clinical evaluation. Coya is developing therapies that target systemic inflammation and neuroinflammation, with additional research platforms involving Treg-enhancing biologics, Treg-derived exosomes and autologous Treg cell therapy. The next major milestones for COYA 302 include initiation of the OLE, completion of the controlled ALSTARS study and release of topline results, followed by continued evaluation of the candidate’s clinical potential.

Source::Coya Therapeutics, press release