other material
confidence high
sentiment neutral
materiality 0.50
Coya to launch OLE of COYA 302 ALS trial in Nov 2026; FTD Phase 2 slips to 2027
Coya Therapeutics, Inc.
- Open-label extension of the Phase 2/3 ALSTARS Trial (NCT07161999) for COYA 302 in ALS expected to begin November 2026 as the first cohort completes the 48-week treatment period.
- OLE initiated in response to requests from ALSTARS investigators and participants; it will gather longer-term efficacy and safety data on COYA 302.
- Phase 2 trial of COYA 302 in frontotemporal dementia, previously expected in H2 2026, is now expected in 2027 as resources are prioritized to the ALS program.
- Cash runway guidance unchanged: existing cash expected to fund operations into H2 2027, beyond the anticipated ALSTARS topline readout.
- ALSTARS design: ~120 patients randomized 1:1:1; 24-week double-blind phase plus 24-week blinded active extension; primary endpoint is ALSFRS-R change at Week 24.