FILAMENT HEALTH ANNOUNCES FDA OPENING OF INVESTIGATIONAL NEW DRUG APPLICATION FOR SUBSTANCE USE DISORDERS
The active IND allows initiation of US research with Filament's botanical psilocybin drug candidate for the potential treatment of substance use disorders including OUD
VANCOUVER, BC, Jan. 31, 2024 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (Cboe CA: FH) (FSE: 7QS) ("Filament" or the "Company"), a clinical‐stage natural psychedelic drug development company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for PEX010, its botanical psilocybin drug candidate, for the treatment of Substance use Disorders (SUD).
"The toxic drug crisis is a significant, growing problem in both Canada and the United States," said Benjamin Lightburn, CEO and Co-Founder at Filament Health. "We believe that botanical PEX010 could offer a solution. PEX010 is already under investigation for OUD in Canada and this milestone allows us to build on that progress in the United States. Congratulations to the team at Filament for a major regulatory achievement."
The IND-opening protocol had previously been submitted to Health Canada and had received no objection from the department. In addition, 24 research institutions and licensing partners in Canada, the USA, Europe, and Israel are studying PEX010 for conditions including alcohol use disorder, depression, and coma.
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. 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.
Certain statements and information contained 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 status of patent applications and the ability to secure patents. 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.
SOURCE Filament Health Corp.
MEDIA RELATIONS: Anna Cordon, VP, Communications, [email protected]; INVESTOR RELATIONS: [email protected]
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