Coya Therapeutics, (NASDAQ: COYA) announced today that Health Canada has accepted its Clinical Trial Application (CTA) for COYA 302, a potential breakthrough combination biologic for the treatment of Amyotrophic Lateral Sclerosis (ALS).
The "No Objection Letter" allows the Houston-based biotech to activate Canadian clinical sites, broadening the recruitment pool for its ongoing Phase 2 ALSTARS trial.
The decision to expand into Canada follows the successful launch of the trial in the United States earlier this year.
By adding Canadian centers, Coya aims to accelerate the enrollment of 120 participants for the 24-week, double-blind, placebo-controlled study.
The trial is designed to evaluate whether COYA 302 can slow the progression of ALS by addressing the systemic and neuroinflammation that drives the disease.