Coya Therapeutics closed enrollment in its Phase 2/3 ALSTARS trial on October 5, reaching its planned 120 patients for COYA 302, a combination of low-dose IL-2 and CTLA-4 Ig (abatacept) in ALS. Topline data from the double-blind treatment phase are expected in early Q2 2027, which is the date that will tell whether an immunomodulatory approach can do something the two drugs ALS physicians have relied on for decades, riluzole and edaravone, cannot: slow the immune-driven neuroinflammatoin driving the disease rather than target downstream pathology.
The mechanism is the reason this readout will draw attention beyond Coya’s size. COYA 302 pairs low-dose IL-2, which selectively expands regulatory T cells, with abatacept, a CTLA-4 fusion protein that dampens effector T-cell activation. The rationale is that ALS patients show deficient and dysfunctional Tregs, and that restoring immune regulation may reduce the neuroinflammatory burden accelerating motor neuron loss. That is a different target than anything currently approved, though 120 patients is a small population to generate a clean efficacy signal in a disease as heterogeneous as ALS.
The filing also notes that additional participants already in active screening will be allowed to enroll, which suggests the final patient count could edge above 120. That detail matters for statistical power: ALS trials routinely lose participants to rapid disease progression, and any buffer in the enrolled population reduces the risk that attrition forces an underpowered primary analysis. The trial design as a Phase 2/3 also means a positive result could move directly toward a regulatory submission rather than requiring a separate confirmatory study, compressing the path to a potential approval substantially.
The number to watch between now and Q2 2027 is not enrollment itself but dropout rate during the blinded treatment phase. If attrition stays low enough to preserve the 120-patient intent-to-treat population, Coya arrives at its readout with the statistical footing the trial was designed around; if it doesn’t, the topline analysis gets harder to interpret regardless of the direction of the efficacy signal.
Source link: https://www.sec.gov/Archives/edgar/data/1835022/000119312526413218/d95167d8k.htm
COYA 302: the facts in one place
- Also written: COYA302
- Sponsor: Coya Therapeutics, Inc., in collaboration with Dr. Reddy’s Laboratories
- Mechanism: Dual immunomodulatory combination of low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig (biosimilar candidate for abatacept); enhances regulatory T cell function and suppresses inflammation caused by activated monocytes and macrophages
- Indication studied: Amyotrophic Lateral Sclerosis (ALS)
- Phase: 2/3
- Enrollment: 120
- Primary endpoint: Change in ALSFRS-R total score from baseline to Week 24
- Registry identifier: NCT07161999
- Current status: Investigational; enrollment complete; not approved by regulatory agencies; topline results anticipated early Q2 2027
- FDA IND acceptance: August 25, 2025
- ALSTARS trial launch: September 22, 2025
- FDA Fast Track Designation for ALS: May 12, 2026
- Full enrollment completed: October 5, 2026
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.
