Biotechnology company Coya Therapeutics Inc (NASDAQ: COYA) announced on Wednesday that it plans to initiate an open-label extension of its Phase 2/3 ALSTARS trial evaluating COYA 302 in amyotrophic lateral sclerosis (ALS), following requests from investigators and participants. Expected to begin in November 2026, the extension will allow eligible participants completing 48 weeks of treatment to continue therapy while providing longer-term safety and efficacy data.
The company is prioritising resources towards COYA 302's development in ALS and key ALSTARS milestones. As a result, its planned Phase 2 trial of COYA 302 in frontotemporal dementia, previously expected in the second half of 2026, has been deferred to 2027.
Coya's cash runway guidance remains unchanged, with existing resources expected to fund operations into the second half of 2027, beyond the anticipated ALSTARS topline results in early Q2 2027. COYA 302 is an investigational biologic combination designed to modulate immune responses and is not approved by any regulatory authority.
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