ALS Trial Enters Extension Phase for COYA 302

Coya Therapeutics has commenced the blinded extension phase of its ALSTARS clinical trial. This trial is investigating COYA 302 as a potential treatment for adults diagnosed with amyotrophic lateral sclerosis (ALS). The study aims to evaluate the safety and efficacy of this investigational therapy.

The Phase II ALSTARS trial is being conducted at approximately 20 to 25 locations throughout Canada and the United States. Following an initial 24-week double-blind, placebo-controlled period, eligible patients can enter this extended phase.

During the extension, participants who finished the initial stage will continue their assigned treatment. Patients originally receiving a placebo will be re-randomized to one of two COYA 302 dosing regimens for up to an additional 24 weeks. This design permits the collection of comprehensive data on COYA 302 over a 48-week period.

COYA 302 is a proprietary biologic combination therapy that targets the enhancement of regulatory T cell (Treg) function and the reduction of inflammation. Its formulation includes low-dose interleukin-2 (LD IL-2) and a biosimilar candidate for abatacept (DRL_AB). Key assessments within the trial include standard ALS clinical outcome measures like the ALSFRS-R, neurofilament levels, and respiratory function tests.

Fred Grossman, President and Chief Medical Officer at Coya Therapeutics, expressed satisfaction with the trial's progress, highlighting the hope for a transformational new treatment for ALS. He also extended gratitude to the patients, families, and caregivers for their crucial contributions to the ALSTARS Trial.