ALSTARS Enters Recruitment Phase

Coya Therapeutics (COYA) is conducting the ALSTARS Phase 2 clinical trial (NCT07161999) at approximately 25 sites in the United States and Canada, enrolling 120 patients with Amyotrophic Lateral Sclerosis (ALS). Unlike the previously titled Phase 2/3 trial, the officially registered phase is Phase 2, with the first patient dosed in December 2025. As of May 2026, recruitment is ongoing, and some initial patients have completed the 24-week treatment and entered the extension phase, with the goal of completing enrollment in the second half of 2026. The primary completion and overall completion dates are set for January 2027 and July 2027, respectively.

Simultaneously Modulating Two Immune Axes

COYA 302 is a subcutaneous composite drug in the pre-commercial approval stage, combining a proprietary low-dose interleukin-2 with DRL_AB from Dr. Reddy’s Laboratories (RDY). The low-dose IL-2 increases the number and anti-inflammatory function of regulatory T cells (Tregs) with high-affinity IL-2 receptors, while DRL_AB, a biosimilar candidate to abatacept (the active ingredient in Orencia), contains CTLA-4 Ig, which blocks CD80 and CD86, inhibiting the activation of monocytes, macrophages, and effector T cells. This differs from existing treatments like Rilutek and Edaravone, which target glutamate toxicity and oxidative stress, respectively, by targeting two complementary axes of neuroinflammation.

Validating Functional Decline and Biomarkers Together

Participants are randomized in a 1:1:1 ratio to two COYA 302 dose groups and a placebo group, receiving a double-blind treatment for 24 weeks. Subsequently, in the 24-week extension phase, the placebo group is re-randomized to one of the two doses, allowing for the evaluation of safety and sustained efficacy for up to 48 weeks. The evaluation framework includes the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), neurofilament light chain (NfL), and maximum inspiratory pressure and forced vital capacity, cross-validating function, axonal damage, and respiratory function. The key to increasing value lies in replicating the signals from the previous small, open-label study with data from 120 patients in a placebo-controlled setting.

Regulatory, Market, and Competitive Landscape

The FDA approved the Investigational New Drug (IND) application for COYA 302 for ALS in August 2025, and Health Canada also approved the clinical trial application; however, the current phase is Phase 2, so it has not yet reached the stage of product approval or advisory committee (AdComm) review. The current standard of care in the United States includes Rilutek (riluzole), approved in 1995, Radicava (edaravone), approved in 2017 for intravenous administration and in 2022 for oral administration, and Qalsody (tofersen), approved in 2023 with accelerated approval for SOD1-mutant ALS. Relyvrio, approved in 2022, was withdrawn from the US and Canadian markets in 2024 after failing to confirm efficacy in a Phase 3 trial, highlighting the importance of reproducible, placebo-controlled evidence. The global ALS therapeutics market is projected to reach USD 789.4 million in 2026 and USD 987.6 million in 2030, and COYA 302 targets a commercial position as an immunomodulatory candidate without genetic limitations.