Psyence Biomedical Ltd. (Nasdaq: PBM) is making strides in its Phase IIb clinical trial, evaluating nature-derived psilocybin combined with psychotherapy for Adjustment Disorder in palliative care patients diagnosed with life-limiting cancer. The trial's progress underscores a commitment to addressing the unmet mental health needs within palliative care.
Two trial sites in Australia, Vitalis and EMPAX, are now active and have initiated patient screening. Psyence Biomed anticipates the first patients will be randomized into the study in January. Therapist training is also underway at both sites, with the company considering additional sites to expand the trial's reach.
Patient Recruitment Strategies
To bolster patient enrollment, Psyence Biomed's contract research organization (CRO), iNGENū CRO, has engaged ACTioN SMO. ACTioN will focus on patient recruitment strategies through social media and direct email communications to physicians, potential clinical trial sites, and disease state advocacy groups, including those in oncology, primary care, and psychiatry.
Dr. Clive Ward-Able, Medical Director of Psyence Biomed, stated, “In collaboration with iNGENū and ACTioN, we have made substantial progress advancing start-up activities related to our Phase IIb trial, and we are poised to commence patient randomization and treatments shortly after this holiday season. With assistance from the team at ACTioN and their proven patient and provider outreach capabilities, we anticipate that the desired recruitment rate will progress smoothly. We look forward to topline results from this trial in the second half of 2025.”
ACTioN's Role
David Harford, Managing Director of ACTioN, added, “We are proud to support Psyence Biomed’s innovative research into the potential of nature-derived psilocybin as a treatment for Adjustment Disorder in the Palliative Care setting. This study aligns with our mission to foster groundbreaking clinical advancements. At ACTioN, we will focus on patient recruitment and retention strategies, which are critical to the study’s success. We are committed to assisting sites in achieving their recruitment goals and ensuring the study’s smooth execution.”
Trial Design
The randomized, double-blind, placebo-controlled study will evaluate two therapeutic doses of nature-derived psilocybin (10mg and 25mg) against an active low-dose comparator (1mg) in 87 patients. The company expects to randomize the first patients into the study in January 2025, with topline results anticipated in the second half of 2025.
This Phase IIb trial aims to explore the potential of psilocybin-based therapy as a treatment for mental health challenges in palliative care, addressing a significant unmet need for patients dealing with emotional distress from a terminal cancer diagnosis.
