Psyence Biomedical Ltd (NASDAQ: PBM), an associate of Psyence Group Inc, has announced the recruitment of Empax Center in Perth, Australia, as the second clinical trial site for its ongoing Phase IIb clinical trial. This trial is evaluating nature-derived psilocybin as a potential treatment for Adjustment Disorder in palliative care patients. The addition of Empax Center, a facility specializing in mental health treatments including psychedelic-assisted therapies, aims to expedite patient enrollment and treatment.
Trial Design and Objectives
The Phase IIb trial is designed to assess the efficacy and safety of psilocybin in alleviating Adjustment Disorder among individuals undergoing palliative care. Adjustment Disorder is a common condition characterized by emotional or behavioral symptoms in response to an identifiable stressor, and it can significantly impact the quality of life for patients in palliative care. The trial's primary endpoint is to determine the therapeutic potential of psilocybin in this patient population.
Dr. Clive Ward-Able, Medical Director of Psyence Biomed, stated that the collaboration with Empax Center will facilitate efficient enrollment in this important study. He anticipates initiating patient treatments soon and is optimistic that positive topline data in the second half of 2025 will pave the way for pivotal registrational studies.
Empax Center's Role
Empax Center is a purpose-built facility dedicated to delivering emerging treatments for serious mental health conditions. The center offers comprehensive care and is staffed by experienced mental health professionals, including authorized prescribers of psychedelic-assisted therapies in Australia. Their expertise will be crucial in supporting both the research and client care aspects of the trial.
Anticipated Timeline
Patient screening at the trial sites is expected to begin imminently, with the first subject anticipated to be randomized into the study in early December. The topline data from the Phase IIb trial is expected in the second half of 2025. Jody Aufrichtig, Executive Chairman of the board of Psyence Group, expressed enthusiasm for the progress of Psyence Biomed's Phase IIb study and looks forward to further updates on patient enrollment and first patient dosing.
