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FILAMENT HEALTH ANNOUNCES FDA AUTHORIZATION OF PHASE 2 CLINICAL TRIAL STUDYING PEX010, THE COMPANY'S BOTANICAL PSILOCYBIN DRUG CANDIDATE, IN OPIOID USE DISORDER
The University of Pennsylvania-sponsored trial will study PEX010 for the treatment of opioid use disorder and the effect on neurocognitive, behavioral, and clinical outcomes
VANCOUVER, BC, April 9, 2025 /CNW/ - Filament Health Corp. (OTCQB:FLHLF) (CBOE:FH) (FSE:7QS) ("Filament" or the "Company"), a clinical‐stage natural psychedelic drug development company, today announces that the United States Food and Drug Administration (FDA) has authorized a phase 2 clinical trial study of its lead drug candidate, PEX010, at the University of Pennsylvania. The trial will study the effects of psychedelic-assisted psychotherapy (PAP) in the treatment of opioid use disorder (OUD), and is funded by the Wellcome Leap, a non-profit organization focused on accelerating breakthroughs in human health, as part of its Untangling Addiction Program.
Filament Health Logo (CNW Group/Filament Health Corp.)
"Opioid use disorder is a significant public health issue and a major contributor to the growing overdose crisis in North America," said Dr. Anna Rose Childress, Director of the Brain-Behavioral Vulnerabilities Laboratory at the Perelman School of Medicine and Principal Investigator for the trial. "This trial will assess the safety and feasibility of delivering natural psilocybin in the treatment of OUD, and evaluate potential changes in participants' opioid use. We are grateful to Filament Health for facilitating this important research."
Escalating cases of OUD worldwide emphasize a critical need for the development of innovative treatments that address associated challenges, including neurocognitive difficulties and poor clinical outcomes such as relapse and non-adherence to life-saving opioid medications. Preliminary findings with PEX010 in alcohol use disorder have encouraged testing in the opioid domain, where overdose deaths in the US exceed 80,000 per year. The studies with PEX010 in OUD will be an important initial step in determining the medication's promise in addressing the opioid crisis. The clinical trial at the University of Pennsylvania will focus on the impact of PEX010 on clinical outcomes, with additional measures (e.g., neurocognition) to help predict which patients may be most likely to benefit from this treatment option.
"We're thrilled to announce FDA authorization for the study of PEX010 at one of the world's most esteemed medical institutions," said Lisa Ranken, Chief Operating Officer at Filament Health. "This significant achievement highlights our key role in facilitating psychedelic research as a leading supplier of clinical-grade natural psilocybin."
"This trial reflects the kind of bold, high-impact work we envisioned when launching the Untangling Addiction program," said Dr. Kevin Jones, Program Director at Wellcome Leap. "Dr. Childress and her team are renowned leaders in addiction neuroscience, and we're proud to support their effort to explore psilocybin-assisted therapy for opioid use disorder. This study is a key part of our mission to advance innovative, neuroscience-driven approaches to understanding and treating addiction."
The trial at the University of Pennsylvania is expected to begin dosing in by Q3 2025. PEX010 is authorized for investigation in 51 clinical trials worldwide for 14 mental health indications.
Closing of Private Placement
Filament Health also announces that further to its press release dated April 3, 2025, it has completed its previously announced financing for total net proceeds of over C$960,000, an increase from its planned offering of C$900,000.
ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (CBOE CA:FH) (FSE:7QS) 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.
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.
