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Coya Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug (IND) Application for COYA 302 for the Treatment of Frontotemporal Dementia (FTD)

  • Coya Therapeutics (NASDAQ: COYA) announced FDA acceptance of its Investigational New Drug (IND) application for COYA 302 to treat frontotemporal dementia (FTD).
  • FTD is the most common dementia form in individuals under 65, affecting approximately 60,000 Americans with an average onset age of 58 & no current treatments to halt disease progression.
  • COYA 302 is an investigational biologic combination therapy consisting of low-dose interleukin-2 (LD IL-2) & CTLA-4 Ig designed to enhance regulatory T cell (Treg) function & suppress neuroinflammation.
  • The therapy is administered subcutaneously & targets systemic inflammation & neuroinflammation associated with neurodegenerative diseases.
  • Dr. Adam Boxer, a UCSF neurology professor & FTD expert, endorsed the scientific rationale for moving COYA 302 into well-controlled clinical trials for sporadic FTD.
  • Coya Chief Medical Officer Dr. Fred Grossman highlighted evidence linking neuroinflammation to FTD progression & the dual mechanism of COYA 302 as a strong basis for evaluation.
  • The company expects to announce topline results from a previously announced investigator-initiated open-label study on low-dose IL-2 & CTLA4-Ig for mild-to-moderate FTD in the coming weeks.
  • Coya is concurrently conducting the ALSTARS Trial (NCT 07161999), a Phase 2, randomized, double-blind, placebo-controlled study evaluating COYA 302 for ALS treatment.
  • Coya Therapeutics is a clinical-stage biotechnology company headquartered in Houston, TX, developing Treg-enhancing biologics, exosomes, & autologous Treg cell therapies.
  • COYA 302 remains an investigational product not yet approved by the FDA or any other regulatory agency.