Coya Advances COYA 302 in Phase II ALS Trial with Eye on Early Approval

Coya Therapeutics is advancing its lead candidate, COYA 302, into a Phase II study as it pursues potential approval for treating amyotrophic lateral sclerosis (ALS). The move follows encouraging Phase I results showing slowed disease progression and improved T-regulatory cell (Treg) function. After aligning with the FDA, the company launched the ALSTARS trial, which aims to enroll 120 patients across the US and Canada. The study will compare biweekly and monthly dosing of COYA 302 against placebo over an initial six-month period, followed by a blinded extension. The primary endpoint is change in ALSFRS-R scores.

COYA 302 combines low-dose IL-2 and CTLA-4 to boost Tregs and reduce inflammation—an approach inspired by Nobel Prize-winning work. Coya believes this mechanism could address major unmet needs in ALS and may extend to other neuroinflammatory diseases. The company is also preparing studies in frontotemporal dementia and exploring broader applications such as Parkinson’s disease.

25-11-2025