Coya Plans ALS Trial Extension, Pushes FTD Trial to 2027
Coya expects to begin an open-label extension of its Phase 2/3 ALSTARS trial of COYA 302 in ALS in November 2026. The company now expects its Phase 2 FTD trial to start in 2027; cash runway guidance remains into H2 2027.
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12:03:08 PM UTC
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OLE planned in response to requests from ALSTARS investigators and participants Eligible participants completing 48 weeks of treatment will have the opportunity to continue receiving COYA 302 Cash runway guidance remains unchanged into the second half of 2027, beyond anticipated ALSTARS topline data readout in early Q2 Coya Therapeutics, Inc. (NASDAQ: COYA ) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance T-cell (Treg) function in patients with neurodegenerative disorders, today announced plans to initiate an open-label extension (OLE) of the Phase 2/3 ALSTARS Trial ( NCT07161999 ) evaluating COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS). Coya plans to initiate the OLE in response to requests from ALSTARS investigators and study participants. The OLE will provide participants who complete the 48-week treatment period with the opportunity to continue receiving COYA 302, while enabling the collection of longer-term efficacy and safety data. Coya expects the OLE to begin in November 2026 as the first cohort completes the 48-week treatment period. Concurrent with the anticipated initiation of the OLE, Coya expects to prioritize resources toward the ongoing clinical development of COYA 302 in ALS and assuring timely completion of important near-term milestones in the ALSTARS trial. With this prioritization, the planned initiation of the Phase 2 clinical trial evaluating COYA 302 in frontotemporal dementia (FTD), previously anticipated in the second half of 2026, is now expected in 2027. The Company’s cash runway guidance remains unchanged, with existing cash resources expected to fund operations into the second half of 2027, beyond the anticipated ALSTARS topline data readout.