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

Cision Canada

07-07-2025

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)
Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.
Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn.
FORWARD LOOKING INFORMATION
Certain statements and information contained in this press release and the documents referred to herein may constitute "forward–looking statements" and "forward–looking information," respectively, under Canadian securities legislation. Generally, forward–looking information can be identified by the use of forward–looking terminology such as, "expect", "anticipate", "continue", "estimate", "may", "will", "should", "believe", "intends", "forecast", "plans", "guidance" and similar expressions are intended to identify forward–looking statements or information. The forward–looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward–looking statements. Forward–looking statements regarding the Company are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward–looking statements or forward–looking information, including the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward– looking statements and forward–looking information. Filament will not update any forward–looking statements or forward–looking information that are incorporated by reference herein, except as required by applicable securities laws.