Psyence Biomed adds Australian site for psilocybin trial

Press Release

NEW YORK – Psyence Biomedical Ltd. (NASDAQ:PBM), a biotechnology company specializing in nature-derived psychedelic medicines, has announced the addition of Empax Center in Perth, Australia, as a second site for its Phase IIb clinical trial. The trial is investigating the use of psilocybin, a naturally occurring psychedelic compound, for the treatment of Adjustment Disorder in palliative care patients.

Empax Center, known for its expertise in mental health and psychedelic-assisted therapies, will play a crucial role in patient recruitment and trial execution. Dr. Clive Ward-Able, Medical Director of Psyence Biomed, expressed confidence in the center’s ability to conduct the trial efficiently and looked forward to initiating patient treatments soon. The company aims to release topline data from the study in the second half of 2025, which, if positive, could lead to pivotal registration studies.

Michael Winlo, CEO of Empax Centre, conveyed enthusiasm for participating in the trial, emphasizing the center’s commitment to innovative care for patients experiencing severe distress due to terminal cancer diagnoses.

Psyence Biomed has partnered with Fluence for professional education and training in psychedelic therapy research and with iNGENū CRO Pty Ltd, an Australian clinical research organization, to support the study. Following the successful export of the drug product PEX010 to Australia in July, the affiliated trial sites are set to begin screening patients, with the first participant expected to be enrolled in early December.

Psyence Biomed is the first company developing non-synthetic psilocybin-based medicines to be listed on . They are focused on addressing the unmet needs of mental health disorders in palliative care settings. Empax Center is a dedicated facility for emerging mental health treatments in Western Australia, staffed by experienced professionals and authorized prescribers of psychedelic-assisted therapies.