NEW YORK, December 17, 2024 — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today highlighted recent progress that has been made with its active Phase IIb clinical trial of nature derived psilocybin, in conjunction with psychotherapy, as a potential treatment for Adjustment Disorder following a life-limiting cancer diagnosis in Palliative Care.
To date, two trial sites in Australia – Vitalis and EMPAX – have been activated, and patient screening has commenced. Psyence Biomed anticipates that the first patients will be randomized into the study in January. Additionally, therapist training is ongoing at both sites. Psyence Biomed is also evaluating additional sites to potentially participate in the trial.
To augment its own patient enrollment initiatives, Psyence Biomed’s contract research organization (CRO), iNGENū CRO, has engaged ACTioN SMO to focus on patient recruitment strategies through social media as well as direct email communications to physicians, potential clinical trial sites and disease state advocacy groups, including in the areas of oncology, primary care and psychiatry. ACTioN SMO is working closely with the activated sites, and the initial outreach to a broad audience has occurred.
Dr. Clive Ward-Able, Medical Director of Psyence Biomed, commented, “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.”
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.”
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicines to be listed on Nasdaq. Psyence is initially working to address the unmet needs of patients who suffer from mental health disorders in the context of Palliative Care. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, regulatory-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Learn more at www.psyencebiomed.com and on LinkedIn.
Contact Information
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com