Psyence Biomedical Ltd. (PBM) has reached a significant milestone in its quest to bring psychedelic-based treatments to the forefront of healthcare. The company announced the initiation of the first clinical trial site in Australia for its Phase IIb study investigating the potential of naturally derived psilocybin as a treatment for Adjustment Disorder in patients receiving palliative care. This marks a crucial step toward advancing psychedelic medicine within the healthcare industry.
The trial, conducted in partnership with Fluence, a leading force in psychedelic therapy research, and iNGENū CRO Pty Ltd, a prominent Australian clinical research organization, aims to delve into the efficacy of Psyence’s naturally sourced psilocybin drug, PEX010. Patient screening is set to begin immediately, with the first participant expected to be randomized in October.
Dr. Clive Ward-Able, medical director of Psyence Biomedical, expressed his enthusiasm for this significant milestone. “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. Dr. Ward-Able emphasized that the data from this study, anticipated in the second half of 2025, could be pivotal in paving the way for a Phase III clinical program.
The study will meticulously investigate the effects of psilocybin on individuals suffering from Adjustment Disorder, particularly those facing the challenges of 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), all in conjunction with psychotherapy. The trial will enroll a total of 87 participants.
Veronika Simic, senior clinical project manager at iNGENū, highlighted the immense 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 underscored iNGENū’s commitment to working efficiently with Psyence Biomedical to advance the study. The export of PEX010 to Australia earlier this year was a critical preparatory step, and the activation of the trial site signifies significant progress in exploring the therapeutic potential of naturally derived psilocybin. This research holds immense promise for the future of mental health treatments and underscores the growing interest in psychedelic medicine as a potential solution for a wide range of conditions.
