Psyence Biomed Ltd. (Nasdaq: PBM) has announced the recruitment of Empax Center, located 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 patients receiving palliative care.
The addition of Empax Center, a facility specializing in mental health treatments including psychedelic-assisted therapies, is expected to accelerate patient enrollment. Dr. Clive Ward-Able, Medical Director of Psyence Biomed, anticipates initiating patient treatments soon and expects topline data in the second half of 2025. Positive results could pave the way for pivotal registrational studies.
Trial Details and Objectives
The Phase IIb trial aims to assess the efficacy and safety of PEX010, Psyence Biomed's nature-derived psilocybin formulation, in alleviating Adjustment Disorder among palliative care patients. Adjustment Disorder is characterized by emotional or behavioral symptoms in response to an identifiable stressor, such as a terminal cancer diagnosis.
Michael Winlo, Chief Executive Officer of Empax Centre, expressed enthusiasm for supporting the trial, emphasizing its potential to advance innovative care for patients facing severe existential distress. Empax Center aims to provide a positive study experience through its skilled team and specialized facilities.
Collaborations and Progress
Psyence Biomed has partnered with Fluence, a leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd, an Australian clinical research organization, to support the study. The company successfully exported the drug product, PEX010, to Australia in July, marking a crucial step in preparing for the trial's initiation. Patient screening is expected to commence shortly, with the first subject anticipated to be randomized into the study in early December.
About Psyence Biomed
Psyence Biomed is focused on developing nature-derived psilocybin-based psychedelic medicines to address unmet needs in mental health disorders within the context of palliative care. The company is committed to an evidence-based approach to developing safe and effective, regulatory-approved therapeutics.
