Coya's ALSTARS trial to test whether Treg biologic slows ALS decline
The randomized, placebo-controlled Phase 2 trial is still enrolling toward a Q1 2027 readout window, with no direct precedent yet for a Treg-targeting combination in ALS.
Executive Summary
- Coya Therapeutics is running a randomized, placebo-controlled Phase 2 trial testing whether a Treg-modulating combination therapy can alter the functional decline that defines ALS, with topline data guided for early 2027.
- The design, randomization, a placebo arm, and a validated functional endpoint, gives the readout the structure to produce a decision-grade signal rather than a hypothesis-generating one.
- No other trial in ALS shares this mechanism, so the result will be judged against the field's broader history of ALS mechanisms that failed to alter disease course, not against a specific rival's data.
- Enrollment is on track and the protocol has not changed since the trial opened, which removes execution risk as a factor in whether the readout lands on schedule.
The trial
ALSTARS (NCT07161999) is testing COYA 302, a combination of low-dose interleukin-2 and a CTLA4-Ig fusion protein designed to enhance regulatory T-cell function, against placebo in adults with ALS. The primary endpoint is the change in disease progression measured by the Revised ALS Functional Rating Scale (ALSFRS-R), a 12-item scale tracking motor and respiratory function that is the standard measure of ALS decline. The trial is randomized with a placebo comparator arm and enrolls patients within 28 months of symptom onset, with an ALSFRS-R score of 35 or higher at screening and a baseline progression rate between 0.5 and 1.5 points per month, criteria designed to capture a population still declining but not yet at the disease's most advanced stage. NCT07161999Study of COYA 302 for the Treatment of ALSNCT07161999
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The stake
Coya's chief executive, Dr. Arun Swaminathan, wrote in a January 2026 letter to stockholders that the ALSTARS trial is "advancing as planned" and that patients are "actively enrolling" and "already being dosed," with more than 20 U.S. sites and newly activated Canadian sites following acceptance of the company's Clinical Trial Application by Health Canada. The trial targets 120 patients across the United States and Canada, with a primary completion date of January 1, 2027 and full study completion guided for July 2027. Coya has told stockholders the ALSTARS study is designed to test whether combination-based Treg modulation can stabilize or alter ALS progression, a result the company has called a potential milestone if confirmed. Coya+1Coya Therapeutics CEO Dr. Arun Swaminathan Issues Letter to StockholdersJan 20, 2026Study of COYA 302 for the Treatment of ALSNCT07161999
Operational status
The trial moved from Not yet recruiting to Recruiting on October 1, 2025, and enrollment has held flat at its 120-patient target with no increase or reduction since. The protocol has seen no change to the primary completion date, no endpoint amendment, and no primary-outcome change after completion, a pattern that reads as a stable, on-track study rather than one showing signs of operational strain. NCT07161999Study of COYA 302 for the Treatment of ALSNCT07161999
The competitive frame
No active trial in ALS shares COYA 302's regulatory T-cell target, and the nearest trials studying the same target class operate in different diseases and different modalities, including a Roche antibody in bladder cancer and several cell-therapy or antibody programs in tumors and autoimmune disease. Within ALS itself, the active field spans mechanistically distinct approaches, including AB Science's KIT inhibitor masitinib and Brainstorm Cell Therapeutics' cell-therapy candidate debamestrocel, both in Phase 3, neither sharing COYA 302's Treg-targeting mechanism. That leaves ALSTARS without a controlled precedent for this specific mechanism-indication pairing, meaning the readout will be assessed against ALS's broader record of therapies that failed to demonstrate a durable effect on functional decline, rather than against a comparable trial result.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.