Psyence Biomed Adds Second Site for Phase IIb Psilocybin Trial in Palliative Adjustment Disorder

Psyence Biomedical Ltd., a pioneer in the development of nature-derived psilocybin-based psychedelic medicines, has announced the recruitment of Empax Center in Perth, Australia, as the second site for its ongoing Phase IIb clinical trial. This trial aims to explore the potential of psilocybin as a treatment for Adjustment Disorder in palliative care settings.

Empax Center brings a wealth of expertise in conducting clinical trials for mental health and neurological conditions, positioning itself as a cutting-edge facility specializing in therapies that include psychedelic-assisted treatments. Dr. Clive Ward-Able, the Medical Director of Psyence Biomed, expressed enthusiasm about the collaboration, noting that Empax Center's involvement will enhance the efficiency and speed of the trial's enrollment process. He also emphasized the goal of initiating patient treatments soon, with an eye on gathering topline data by the second half of 2025, potentially paving the way for pivotal registrational studies.

Michael Winlo, the Chief Executive Officer of Empax Center, shared his optimism about the partnership. He highlighted the trial's significance in advancing care for patients experiencing severe existential distress and Adjustment Disorder due to recent terminal cancer diagnoses. Winlo reiterated Empax Center's commitment to innovative mental health treatments and the importance of ensuring a positive study experience for patients through their skilled team and specialized facilities.

In addition to Empax Center, Psyence has partnered with Fluence, a global leader in professional education for psychedelic therapy research, and iNGENū CRO Pty Ltd, an Australian clinical research organization, to support the study. In a significant development, Psyence successfully exported its psilocybin drug product, PEX010, to Australia in July, marking a key preparatory step for the trial. The trial sites will soon commence patient screening, with the first subject expected to be randomized into the study by early December.

Located in Perth, Western Australia, Empax Center is dedicated to delivering emerging treatments for serious mental health conditions with a focus on safety and client-centered care. The center is staffed by experienced mental health professionals, including some of Australia's first authorized prescribers of psychedelic-assisted therapies, to ensure both research and client care are of the highest standard.

Psyence Biomedical Ltd., listed on Nasdaq under the ticker PBM, stands out as the first life science biotechnology company to develop non-synthetic psilocybin-based psychedelic medicines and list on the exchange. The company addresses unmet needs in mental health disorders within palliative care settings. The name "Psyence" is a fusion of "psychedelics" and "science," reflecting the company's commitment to evidence-based innovation in developing safe, regulatory-approved psychedelic therapeutics for a variety of mental health disorders.

Psyence is focused on creating treatments grounded in rigorous scientific research and clinical trials to ensure efficacy and safety. The ongoing Phase IIb clinical trial is a step toward achieving this mission, with the potential to bring new hope to patients facing severe mental health challenges associated with terminal illnesses.