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Coya Therapeutics Announces Enrollment of 100th Participant in Phase 2/3 ALSTARS Trial of COYA 302 for the Treatment of ALS

COYA
  • Coya Therapeutics announced the enrollment of the 100th patient in the Phase 2/3 ALSTARS trial (NCT07161999) evaluating COYA 302 for ALS.
  • The company anticipates completing full enrollment of 120 participants in the upcoming weeks.
  • Topline data from the trial is expected in early Q2 2027 based on current screening & enrollment rates.
  • COYA 302 has received FDA Fast Track designation for the treatment of amyotrophic lateral sclerosis.
  • Additional participants are continuing to roll over into the active extension arm of the trial.
  • The ALSTARS trial is a randomized, multi-center, double-blind, placebo-controlled study involving approximately 120 subjects.
  • Participants will receive one of two COYA 302 dosing regimens or placebo during a 24-week double-blind phase.
  • Patients completing the placebo-controlled phase enter a 24-week blinded active-treatment extension phase for up to 48 weeks of data.
  • The primary endpoint is the change in disease severity measured by the ALSFRS-R total score from baseline to Week 24 compared with placebo.
  • COYA 302 is a proprietary biologic combination of low-dose IL-2 & CTLA-4 Ig designed to enhance regulatory T-cell function.