Psyence Biomedical Ltd. has announced the initiation of its Phase IIb clinical trial in Australia, investigating nature-derived psilocybin as a potential treatment for Adjustment Disorder in the context of palliative care. The first site initiation visit has been successfully completed, paving the way for patient screening to begin imminently, with the first subject expected to be randomized into the study in October.
The Phase IIb trial is a randomized, double-blind, placebo-controlled study that will evaluate two therapeutic doses of nature-derived psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 87 patients. All participants will receive concurrent psychotherapy.
Trial Design and Objectives
The study aims to assess the efficacy and safety of psilocybin-assisted psychotherapy in individuals experiencing Adjustment Disorder following a life-limiting cancer diagnosis. The primary endpoint is the change from baseline in a validated measure of adjustment disorder symptoms. Secondary endpoints include assessments of mood, anxiety, and overall quality of life.
Dr. Clive Ward-Able, Medical Director of Psyence Biomedical, stated, "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."
Collaboration and Support
Psyence has partnered with Fluence, a global leader in professional education and training for psychedelic therapy research, and iNGENü CRO Pty Ltd, an Australian clinical research organization (CRO), to support the study. iNGENü CRO Senior Clinical Project Manager, Veronika Simic, noted, "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."
PEX010 and Regulatory Milestones
In July, Psyence announced the successful export of the drug product, PEX010, to Australia, marking a crucial step in preparation for initiation of the study. Topline data from the Phase IIb trial is anticipated in the back half of next year, which, if positive, will support the initiation of a pivotal Phase III clinical program as soon as practicable thereafter.
