FILAMENT HEALTH ANNOUNCES FDA AUTHORIZATION OF PHASE 2 CLINICAL TRIAL STUDYING PSILOCYBIN FOR ALCOHOL USE DISORDER AND POST-TRAUMATIC STRESS DISORDER IN VETERANS AND FIRST RESPONDERS
FILAMENT HEALTH ANNOUNCES FDA AUTHORIZATION OF PHASE 2 CLINICAL TRIAL STUDYING PSILOCYBIN FOR ALCOHOL USE DISORDER AND POST-TRAUMATIC STRESS DISORDER IN VETERANS AND FIRST RESPONDERS |
[07-July-2025] |
The clinical trial at the University of Washington will study Filament's botanical psilocybin drug candidate, PEX010 VANCOUVER, BC, July 7, 2025 /CNW/ - Filament Health Corp. (OTC:FLHLF) ("Filament" or the "Company"), a clinical-stage natural psychedelic drug development company, today announced that the U.S. Food and Drug Administration (FDA) has authorized a phase 2 clinical trial studying the Company's botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in military veterans and first responders. The trial will be led by Dr. Nathan Sackett at the University of Washington School of Medicine's Center for Novel Therapeutics in Addiction Psychiatry. It will be the first clinical trial to study the safety of psilocybin combined with psychological support for the treatment of individuals with both AUD and PTSD. "Despite significant overlap between AUD and PTSD, there is a lack of evidence-based treatment options for people experiencing both conditions, particularly among veterans and first responders, who are disproportionately affected," said Dr. Sackett, Principal Investigator and Assistant Professor in the Department of Psychiatry and Behavioral Sciences. "This study will be the first to investigate the safety of psilocybin-assisted support in this dual-diagnosis population, and we are grateful to Filament for enabling this important research." Military veterans and first responders experience some of the highest rates of co-occurring AUD and PTSD, yet treatment options remain limited and are often ineffective. While psychedelic-assisted therapies have shown promise for each condition individually, no prior trials have evaluated the use of psilocybin for both concurrently. This study will assess the safety of a single 25 mg dose of PEX010 paired with non-directive psychological support, defined by safety monitoring, empathetic presence, and integration sessions. "Veterans and first responders dedicate their lives to protecting others, yet are often left behind with regard to mental health treatments," said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. "We're proud to contribute to this urgently needed research, which could help shape the future of care for those who have given so much to their communities." The trial is funded by the State of Washington and is enrolling now, with results expected by fall 2026. Information regarding enrolment can be found at https://redcap.link/psilostudy. ABOUT FILAMENT HEALTH (OTC:FLHLF) Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn. FORWARD LOOKING INFORMATION
SOURCE Filament Health Corp. | ||
Company Codes: OTC-BB:FLHLF, OTC-PINK:FLHLF |