Psyence Biomed Updates on Ongoing Phase IIb Clinical Trial

Psyence Biomedical Ltd., a pioneering life science biotechnology company listed on Nasdaq, is making significant strides in its Phase IIb clinical trial. This study investigates the use of nature-derived psilocybin, combined with psychotherapy, as a potential treatment for Adjustment Disorder in patients with life-limiting cancer diagnoses who are receiving palliative care. The trial aims to address the mental health challenges faced by these patients.

The trial is currently active at two sites in Australia, Vitalis and EMPAX, where patient screening has already begun. Psyence Biomed aims to randomize the first patients into the study in January. The company is also in the process of identifying additional sites that may participate in the trial. To enhance the effectiveness of its patient recruitment efforts, Psyence Biomed has partnered with iNGENū CRO, which has in turn enlisted the support of the Australian Clinical Trial Network (ACTioN), a leading site management organization specializing in clinical trials. ACTioN is tasked with implementing both patient recruitment and retention strategies.

The collaboration between iNGENū CRO and ACTioN is focusing on reaching potential participants through various channels, including social media and direct email communications with physicians, potential trial sites, and advocacy groups. These efforts target key areas such as oncology, primary care, and psychiatry. The initial outreach to a broad audience is already underway, aiming to build awareness and interest in the trial.

Dr. Clive Ward-Able, Psyence Biomed’s Medical Director, expressed optimism about the progress made in the preparatory stages of the trial. He noted that the collaboration with iNGENū and ACTioN has set the stage for the commencement of patient randomization and treatment soon after the holiday season. Dr. Ward-Able emphasized the importance of ACTioN’s expertise in patient and provider outreach to achieve a smooth recruitment process. The company is keenly anticipating the release of topline results from the trial in the latter half of 2025.

David Harford, Managing Director of ACTioN, highlighted the significance of supporting Psyence Biomed's innovative research. He reiterated ACTioN’s commitment to implementing effective patient recruitment and retention strategies, which are crucial to the study’s success. Harford affirmed ACTioN’s dedication to helping trial sites meet their recruitment targets and ensuring seamless trial execution.

Psyence Biomed stands out as the first company to focus on developing nature-derived psilocybin-based psychedelic medicines for mental health disorders, specifically in the context of palliative care. The name "Psyence" reflects the fusion of "psychedelics" and "science," underscoring the company's commitment to evidence-based innovation. By developing safe and effective psychedelic therapeutics, Psyence Biomed aims to provide regulatory-approved treatments for a wide array of mental health conditions.

The ongoing Phase IIb trial represents a critical step in Psyence Biomed’s mission to address unmet mental health needs, particularly for patients grappling with the psychological challenges of life-limiting illnesses. Through strategic partnerships and robust research, the company is poised to advance its pioneering work in psychedelic medicine. As the trial progresses, Psyence Biomed remains focused on achieving its recruitment goals and delivering valuable insights into the potential benefits of psilocybin-based therapy for Adjustment Disorder in palliative care settings.