Psyence Biomedical doses patients, expands clinical sites in Phase IIb study

Psyence Biomedical (PBM) announced a major clinical milestone with multiple patients successfully dosed in its ongoing Phase IIb clinical trial evaluating nature-derived psilocybin, in combination with psychotherapy, as a potential treatment for Adjustment Disorder in palliative care. Following successful patient dosing across multiple trial sites, the Company is advancing the only active Australian clinical program using a natural psilocybin formulation to treat Adjustment Disorder in palliative care – one of the most rigorous studies of its kind globally. The Phase IIb study has been strategically designed to meet regulatory expectations for pivotal clinical evidence. Its larger sample size, rigorous randomization, and multi-site structure enhance statistical power, data reliability, and the generalizability of findings. Patients have now been dosed across two active clinical sites – the Empax Center in Perth and the Mind Medicine Australia Clinic in Melbourne – reflecting strong operational readiness, recruitment efficiency, and protocol execution. The Company has also activated Paratus Clinical Research in Melbourne to expand the study to three actively enrolling sites and accelerate data collection toward topline results anticipated by year-end 2026. The multi-site, double-blind, placebo-controlled study is designed to enroll 87 patients across Australia. Participants receive one of two therapeutic doses of psilocybin or a low-dose comparator, each administered alongside structured psychotherapy. The study will assess efficacy, safety, and durability of response, with the goal of advancing psilocybin as a potential first-in-class treatment for Adjustment Disorder in palliative care settings.