Coya to Initiate Open-Label Extension of Phase 2/3 ALSTARS Trial of COYA 302 in ALS
Key Highlights
- ➤COYA 302 ALS open-label extension planned to begin November 2026
- ➤Participants completing 48 weeks can continue receiving COYA 302
- ➤FTD Phase 2 trial initiation delayed from second half of 2026 to 2027
- ➤Cash runway remains into second half of 2027, beyond early Q2 topline data
Expert Statements
Fred Grossman, President and Chief Medical Officer of Coya
“The strong interest from investigators and participants in continuing treatment beyond the current 48-week study period underscores the importance of providing continued access to COYA 302 for eligible participants in the ALSTARS trial.”
Fred Grossman, President and Chief Medical Officer of Coya
“The open-label extension will also provide an opportunity to further characterize the long-term safety, tolerability, and potential treatment effects of COYA 302 in people living with ALS.”
David Snyder, Chief Financial Officer of Coya
“As we continue to advance and expand the ALSTARS trial, we believe prioritizing our resources behind COYA 302 in ALS is the appropriate near-term, fiscal, and operational strategy for our Company.”
Coya to Initiate Open-Label Extension of Phase 2/3 ALSTARS Trial of COYA 302 in ALS
* 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).
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