Coya Therapeutics Hits 100-Patient Milestone in ALS Trial, On Track for 2027 Data — Coya Therapeutics, Inc.

Event summary

Coya Therapeutics has enrolled the 100th participant in its Phase 2/3 ALSTARS trial for COYA 302, an ALS treatment.
The trial aims to enroll 120 participants total, with completion expected in early Q2 2027.
COYA 302 combines low-dose IL-2 and CTLA-4 Ig to enhance regulatory T-cell function in ALS patients.
The primary endpoint is measuring disease severity using the ALSFRS-R scale over 24 weeks.

The big picture

Coya's progress in the ALSTARS trial underscores the urgent need for effective ALS treatments, a disease with limited therapeutic options and rapid progression. The trial's design, including a blinded extension phase, aims to provide robust data on COYA 302's long-term efficacy and safety. Success could position Coya as a key player in neurodegenerative disease therapy, leveraging its Treg-focused platform.

What we're watching

Trial Execution: Whether Coya can maintain current enrollment rates to meet the Q2 2027 topline data deadline.
Therapeutic Potential: How COYA 302's dual immunomodulatory mechanism will perform against placebo in altering ALS progression.
Regulatory Pathway: The pace at which positive data could accelerate FDA review or attract partnership interest.