Coya Therapeutics Completes Enrollment in Phase 2/3 ALS Trial

Event summary

Coya Therapeutics has fully enrolled 120 participants in its Phase 2/3 ALSTARS trial for COYA 302, a treatment for ALS.
Topline data from the double-blind treatment phase is expected in early Q2 2027.
COYA 302 combines proprietary low-dose IL-2 and CTLA-4 Ig to enhance T-cell function.
Dr. Reddy’s Laboratories holds exclusive commercialization rights for COYA 302 globally, except in Japan, South America, and Mexico.

The big picture

Coya Therapeutics' completion of enrollment in the ALSTARS trial marks a critical step in evaluating COYA 302 as a potential treatment for ALS, a disease with significant unmet medical needs. The collaboration with Dr. Reddy’s Laboratories underscores the strategic importance of this program, as the partner aims to bring the therapy to global markets. The trial's results will be closely watched, given the limited efficacy of current ALS treatments and the high mortality rate associated with the disease.

What we're watching

Clinical Efficacy: Whether COYA 302 can demonstrate meaningful slowing of ALS progression compared to placebo.
Regulatory Pathway: The pace at which the FDA will review COYA 302, given its Fast Track designation.
Commercialization Strategy: How Dr. Reddy’s Laboratories will execute its global commercialization strategy for COYA 302.