Psyence Biomed Announces Recruitment of Second Clinical Trial Site for Ongoing Phase IIb Clinical Trial of Nature-Derived Psilocybin for Adjustment Disorder in Palliative Care
Empax Center brings significant expertise in clinical trial execution for mental health and neurological conditions
Psyence Biomed on track to begin recruitment this quarter, and to announce Adjustment Disorder topline data in the second half of 2025
NEW YORK, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed" or the "Company") today announced the recruitment of Perth, Australia-based Empax Center as the second trial site for Psyence’s Biomed ongoing Phase IIb clinical trial of nature-derived psilocybin as a potential treatment for Adjustment Disorder in Palliative Care.
“Having Empax Center as our second clinical trial site adds a cutting-edge facility specializing in mental health treatments, including psychedelic-assisted therapies, and also helps position us to enroll this important study as quickly and efficiently as possible,” stated Dr. Clive Ward-Able, Medical Director of Psyence Biomed. “We look forward to initiating patient treatments soon and working towards topline data in the second half of 2025 that, if positive, will support the initiation of pivotal registrational studies shortly thereafter.”
Michael Winlo, Chief Executive Officer of Empax Centre, added, “We are delighted to support this important psilocybin trial, which promises a significant step forward in providing innovative care for patients facing severe existential distress and an adjustment disorder due to a recent terminal cancer diagnosis. At Empax, we’ve always envisioned our center as a place where patients can access the best available care alongside the most promising new treatments in mental health, and we look forward to supporting this trial and ensuring patients have a positive study experience from the expertise of our highly skilled team and purpose-designed facilities.”
Psyence previously announced that 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. In July, Psyence Biomed announced 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 sites will soon commence screening patients, and the first subject is expected to be randomized into the study in early December.
About Empax Center:
Located in Perth, Western Australia, Empax Center is a purpose-built facility dedicated to the safe delivery of emerging treatments for serious mental health conditions. Offering safe, effective, and client-centered comprehensive care, Empax Center is led by a team of experienced mental health professionals, including some of the first authorized prescribers of psychedelic-assisted therapies in Australia, to support both research and client care.
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicines to be listed on Nasdaq. Psyence Biomed is initially working to address the unmet needs of patients who suffer from mental health disorders in the context of Palliative Care. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, regulatory-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Learn more at www.psyencebiomed.com and on LinkedIn.
Forward Looking Statements 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 enrolment of patients at the Empax Center, clinical trial milestones, and obtaining topline data in the second half of 2025. These forward-looking statements are based on a number of assumption the anticipated clinical trial implementation schedule will be adhered to.
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 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 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 maintain the licensing of third-party intellectual property rights and supply of raw materials for future discovery and development of its product candidates; (v) Psyence Biomed’s ability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approved products; (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 (File No. 333 276973) filed with the Securities and Exchange Commission on August 30, 2024 and other documents filed by the Company 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, the Company does not intend to update these forward-looking statements.
The Company makes no medical, treatment or health benefit claims about the Company’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. The Company 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 the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
