Psyence BioMed Doses Multiple Patients and Expands Clinical Sites in Phase IIb Study for Adjustment Disorder in Palliative Care

Core Insights - Psyence Biomedical Ltd. has achieved a significant clinical milestone by successfully dosing multiple patients in its Phase IIb clinical trial for nature-derived psilocybin as a treatment for Adjustment Disorder in palliative care [1][2][5] Company Overview - Psyence Biomedical Ltd. is a biopharmaceutical company focused on developing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, particularly in palliative care [7] - The company is recognized as a global leader in late-stage psychedelic drug development and is the first life sciences biotechnology company specializing in this area to be listed on Nasdaq [2][7] Clinical Trial Details - The Phase IIb study is designed to meet regulatory expectations and includes a larger sample size, rigorous randomization, and a multi-site structure to enhance data reliability and generalizability [3][5] - The trial aims to enroll 87 patients across Australia, with participants receiving either 10 mg or 25 mg of psilocybin or a low-dose comparator of 1 mg, alongside structured psychotherapy [5] - The study will assess the efficacy, safety, and durability of response to psilocybin as a potential first-in-class treatment for Adjustment Disorder in palliative care settings [5][6] Operational Readiness - Patients have been dosed at two active clinical sites in Australia, with plans to expand to a third site to accelerate data collection, with topline results expected by the end of 2026 [4][6] - The operational readiness and recruitment efficiency of the company have been highlighted as key strengths in executing the trial [4][6]