Psyence Biomed (Nasdaq: PBM) has announced the recruitment of Empax Center in Perth, Australia, as the second clinical trial site for its ongoing Phase IIb clinical trial evaluating nature-derived psilocybin for the treatment of Adjustment Disorder in Palliative Care. Patient recruitment is expected to begin this quarter, with topline data anticipated in the second half of 2025.
The trial is supported by partnerships with Fluence and iNGENū CRO. Psyence Biomed successfully exported its drug product PEX010 to Australia in July, and patient screening is set to begin, with the first subject randomization expected in early December.
Strategic Expansion of Clinical Trial Capabilities
The addition of Empax Center, a facility specializing in mental health treatments and psychedelic-assisted therapies, represents a strategic expansion of Psyence Biomed's clinical trial capabilities. Empax Center's expertise is expected to enhance patient recruitment efficiency and the quality of trial execution.
"Having Empax Center as our second clinical trial site adds a cutting-edge facility specializing in mental health treatments, including psychedelic-assisted therapies, and also helps position us to enroll this important study as quickly and efficiently as possible," stated Dr. Clive Ward-Able, Medical Director of Psyence Biomed.
Trial Progress and Timeline
The trial's timeline projections, with topline data expected in H2 2025, align with industry standards for Phase IIb studies. Key operational milestones have been met, including the successful drug export to Australia and partnerships with Fluence and iNGENū CRO. The imminent patient screening and expected first patient randomization in December indicate proper trial progression.
Michael Winlo, Chief Executive Officer of Empax Centre, added, "We are delighted to support this important psilocybin trial, which promises a significant step forward in providing innovative care for patients facing severe existential distress and an adjustment disorder due to a recent terminal cancer diagnosis."
About Adjustment Disorder in Palliative Care
Adjustment Disorder is a condition characterized by emotional or behavioral symptoms in response to an identifiable stressor, such as a serious illness. In palliative care settings, patients often experience significant psychological distress related to their diagnosis and prognosis. Current treatments may include psychotherapy and medication, but there remains an unmet need for more effective and targeted interventions.
Trial Design and PEX010
The Phase IIb trial is designed to evaluate the efficacy and safety of PEX010, a nature-derived psilocybin formulation, in patients with Adjustment Disorder receiving palliative care. The study will assess the impact of PEX010 on various psychological and functional outcomes. Psyence Biomed has partnered with Fluence for professional education and training in psychedelic therapy research and with iNGENū CRO, an Australian clinical research organization, to support the study's execution.
