NEW YORK, Sept. 09, 2024 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”), a developer of naturally derived psilocybin-based therapeutics, today announced that the first site initiation visit has been successfully completed at the first Australian clinical trial site for the Company’s Phase IIb study of nature derived (non-synthetic) psilocybin as a potential treatment for Adjustment Disorder in the Palliative Care context.
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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 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 site will soon commence screening patients, and the first subject is expected to be randomized into the study in October.
“The imminent activation of the first trial site and patient screening for this trial represents a significant milestone for our company, and a positive step forward for the advancement of psychedelic-based therapeutics generally,” said Dr. Clive Ward-Able, Medical Director of Psyence Biomedical. “Together with our partners, iNGENū and Fluence, we will endeavor to quickly enroll this study, and we look forward to topline data in the back half of next year that, if positive, will support the initiation of a pivotal Phase III clinical program as soon as practicable thereafter.”
“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,” said iNGENū CRO Senior Clinical Project Manager, Veronika Simic. “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.”
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.
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Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company focused on the development of botanical (nature-derived and non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. 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, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Psyence is initially focused on mental health disorders in the context of Palliative Care.