Psyence Biomed Begins First Australian Trial Site for Phase IIb Study on Psilocybin for Adjustment Disorder in Palliative Care

Psyence Biomedical Ltd. (Nasdaq: PBM), a developer of psilocybin-based therapeutics, has announced the successful initiation of the first clinical trial site in Australia for its Phase IIb study. This study will explore the potential of naturally derived psilocybin as a treatment for Adjustment Disorder in Palliative Care. The patient screening process is set to begin shortly, with the first participant expected to be randomized in October.

The company has partnered with Fluence, an educational leader in psychedelic therapy research, and iNGENū CRO Pty Ltd, an Australian clinical research organization, to support the study. In July, Psyence successfully exported its drug product, PEX010, to Australia, marking a significant preparatory step for the trial's initiation.

Dr. Clive Ward-Able, Psyence Biomedical's Medical Director, highlighted the importance of this milestone, noting that the activation of the trial site and the upcoming patient screening represent significant progress for the company and the field of psychedelic-based therapeutics. He expressed optimism about the speed of enrollment and the potential of the study to provide supportive data for a pivotal Phase III clinical program.

Veronika Simic, Senior Clinical Project Manager at iNGENū CRO, emphasized iNGENū's experience in conducting psychedelic clinical trials and expressed confidence in the promise of psilocybin as a treatment for various mental health conditions. She noted that the partnership with Psyence Biomedical aims to introduce a novel psilocybin-based treatment to patients dealing with Adjustment Disorder following a life-limiting cancer diagnosis in Palliative Care. Simic affirmed that the study is designed to be advanced efficiently.

The Phase IIb study is randomized, double-blind, and placebo-controlled. It will evaluate two therapeutic doses of naturally derived psilocybin (10mg and 25mg) against a low-dose comparator (1mg) in 87 patients, in conjunction with psychotherapy.

Psyence Biomedical Ltd. is the first life science biotechnology company focused on developing botanical, non-synthetic psilocybin-based psychedelic medicine listed on Nasdaq. The company aims to develop safe and effective nature-derived psychedelic therapeutics to treat a range of mental health disorders, with an initial focus on mental health issues in Palliative Care contexts. Psyence combines the words "psychedelics" and "science" to reflect its commitment to evidence-based innovation.