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Psyence Biomedical Ltd. (NASDAQ:PBM) announced a major milestone on Monday with the initiation of the first clinical trial site in Australia for its Phase IIb study on nature-derived psilocybin as a potential treatment for Adjustment Disorder in patients receiving palliative care. This development marks a key step toward advancing psychedelic-based treatments in the healthcare industry.
The trial, conducted in partnership with Fluence, a leader in psychedelic therapy research, and iNGENū CRO Pty Ltd, a renowned Australian clinical research organization, aims to explore the efficacy of Psyence's naturally sourced psilocybin drug, PEX010. As the company stated, patient screening is set to begin immediately, with the first subject expected to be randomized in October.
Dr. Clive Ward-Able, medical director of Psyence Biomedical, expressed enthusiasm about the trial's progression. “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,” he said. He emphasized that data from the study, expected in the second half of 2025, could pave the way for a pivotal Phase III clinical program.
The study will investigate the effects of psilocybin on patients suffering from Adjustment Disorder, particularly those dealing with life-limiting cancer diagnoses. The randomized, double-blind, placebo-controlled trial will evaluate two therapeutic doses of psilocybin (10mg and 25mg) against an active low-dose comparator (1mg) in conjunction with psychotherapy, enrolling 87 patients.
Veronika Simic, senior clinical project manager at iNGENū, highlighted the potential of psilocybin in addressing unmet mental health needs. “We believe psilocybin holds great promise as a treatment for a broad range of mental health conditions,” Simic stated. She also reaffirmed iNGENū's commitment to efficiently advancing the study in collaboration with Psyence Biomedical.
The export of PEX010 to Australia earlier this year was a crucial preparatory step, and the trial site's activation signals significant progress toward exploring the therapeutic potential of naturally derived psilocybin.
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Posted In: PBM
