Psyence Group's NASDAQ-Listed Associate, Psyence Biomedical, Announces Initiation of First Trial Site in Australia for its Phase IIb Study of Nature Derived Psilocybin as a Potential Treatment for Adjustment Disorder in Palliative Care
NEW YORK, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Psyence Group Inc ("Psyence Group") (CSE: PSYG), a life science biotechnology company pioneering the use of nature-derived psilocybin in mental health and wellbeing, is pleased to announce that its NASDAQ-listed associate, Psyence Biomedical Ltd (NASDAQ: PBM) ("PBM" or "Psyence Biomed"), has successfully completed the first site initiation visit at the first Australian clinical trial site for PBM’s Phase IIb study of nature derived (non-synthetic) psilocybin as a potential treatment for Adjustment Disorder in the Palliative Care context.
According to a news release issued by Psyence Biomed on Monday, September 9, 2024, it has entered into partnerships with Fluence, a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support the study as reported in July as well as the successful export of the drug product, PEX010, to Australia, which marked a crucial step in preparation for initiation of the study. The affiliated trial site will soon commence screening patients, and the first subject is expected to be randomized into the study in October.
According to Veronika Simic, iNGENū's Senior Clinical Project Manager, “As a leading global contract research organization that has notable experience in the execution of psychedelic clinical trials, we believe psilocybin holds great promise as a treatment for a broad range of mental health conditions with unmet needs.” “We are pleased to partner with Psyence Biomedical as they work to introduce a novel, psilocybin-based treatment to patients suffering from Adjustment Disorder following a life limiting cancer diagnosis in Palliative Care, and we are prepared to advance this rigorously designed study as efficiently as possible.”
"We are very pleased that Psyence Biomed has achieved this significant milestone in their Phase IIb study, and look forward to further updates on patient enrollment and first patient dosing," said Jody Aufrichtig, Executive Chairman of the board of Psyence Group.
The randomized, double-blind, placebo-controlled Phase IIb study will evaluate two therapeutic doses of nature-derived psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 87 patients in conjunction with psychotherapy.
Psyence Group currently holds 5,000,000 common shares in Psyence Biomed.
More information on Psyence Biomed's upcoming Phase IIb clinical trial can be found at: 12624000449538p.
About Psyence Group and Psyence Biomed:
Psyence Group is a life science biotechnology company listed on the Canadian Securities Exchange (CSE: PSYG), with a focus on natural psychedelics. Psyence Biomed is the world’s first life science biotechnology company traded on the Nasdaq (NASDAQ: PBM) that is focused on the development of botanical (nature derived, or non-synthetic) psilocybin-based psychedelic medicines, and works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name "Psyence" combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research.
Informed by nature and guided by science, Psyence Group works to develop advanced natural psilocybin products for clinical research and development.
Learn more at www.psyence.com and on Twitter, Instagram and LinkedIn.
This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning.
Forward-looking statements in this communication include statements regarding the safety and effectiveness of psilocybin as a treatment option for adjustment disorder within the context of Palliative Care. These forward-looking statements are based on a number of assumptions, including the assumption that the trial site initiation and patient recruitment will be successful in accordance with the expected timelines, and that trial results will support the initiation of Phase III registrational trials.
There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the ability of Psyence Biomed's contract research partner, iNGENū, to execute its obligations in respect of the clinical trial; (ii) changes in applicable laws which may impact the clinical trial and/or the conducting thereof; (iii) Psyence Biomed's subsidiary, Psyence Australia’s, ability to achieve successful clinical results; (iv) Psyence Biomed’s ability to obtain regulatory approval for its product candidates, and any related restrictions or limitations of any approved products; (v) Psyence Biomed’s ability to obtain licensing of third-party intellectual property rights and supply of raw materials for future discovery and development of its product candidates; (vi) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors, and the other risks and uncertainties described in the "Risk Factors" section of the final prospectus filed by Psyence Biomed with the SEC on August 30, 2024 and other documents filed by Psyence Biomed from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, neither Psyence Group, nor Psyence Biomed intends to update these forward-looking statements.
Neither Psyence Group, nor Psyence Biomed, makes no medical, treatment or health benefit claims about Psyence Biomed’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Psyence Biomed has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that Psyence Biomed verified such in clinical trials or that Psyence Biomed will complete such trials. If Psyence Biomed cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Psyence Biomed’s performance and operations.
