Coya Therapeutics has fully enrolled 120 participants in the Phase 2/3 ALSTARS trial of COYA 302, a combination of low-dose interleukin-2 and CTLA-4 Ig designed to restore regulatory T cell function and dampen neuroinflammation in amyotrophic lateral sclerosis. The primary endpoint is change in ALS Functional Rating Scale-Revised score at 24 weeks, with topline data expected in early Q2 2027. The trial tests whether modulating immune tolerance — rather than targeting motor neurons directly — can alter the trajectory of neurodegeneration.
Key Points
- 120 participants enrolled; topline 24-week data expected early Q2 2027
- COYA 302 pairs low-dose IL-2 with CTLA-4 Ig to boost regulatory T cells
- Design extends to 48 weeks via blinded active-treatment continuation
Longevity Analysis
Regulatory T cell dysfunction is a recognized feature of ALS progression, and its correction represents an approach that treats chronic immune misfiring as the driver rather than a byproduct of neuronal loss. The same inflammatory signaling that erodes motor neurons also underlies broader age-related decline, which makes a controlled readout on immune tolerance restoration relevant well beyond this indication. Whether suppressing maladaptive inflammation translates into measurable functional preservation — not just biomarker movement — is the question the 24- and 48-week endpoints are built to answer.
Original published by LT Wire.