Psyence Biomed Collaborates on Psilocybin Therapy Training for Cancer Patients' Trial

Psyence Biomedical Ltd, a company listed on the Nasdaq and specializing in the development of botanical psilocybin-based psychedelic medicines, has announced a strategic collaboration for a Phase IIb clinical trial. The trial, which is set to begin in the second quarter of 2024, aims to assess the therapeutic potential of psilocybin-assisted psychotherapy for patients diagnosed with Adjustment Disorder following a cancer diagnosis within a palliative care setting. This disorder, which can lead to severe depression and anxiety, affects approximately 19% of cancer patients and is recognized by the World Health Organization as one of the most common psychiatric conditions.
The collaboration includes Psyence Australia Pty Ltd, the Australian subsidiary of Psyence Biomedical Ltd, Fluence, a leading provider of professional education in psychedelic therapy, and iNGENū CRO Pty Ltd, an Australian clinical research organization with expertise in psychedelic pharmaceutical development. Fluence's faculty, known for their expertise in the field, will play a pivotal role in training therapists to a high standard, which is crucial for the success of the trial and the delivery of patient care. Clive Ward-Able, Psyence Biomed’s Chief Medical Officer, emphasized the importance of Fluence's involvement in ensuring the quality of care and contribution to the research on integrating psychedelic-assisted therapy into palliative medicine.
The trial will be a double-blind, placebo-controlled study involving 84 patients and will test three different doses of psilocybin alongside psychotherapy. Psyence Biomed anticipates the primary endpoint results to be available in 2025. The company's CEO, Neil Maresky, expressed enthusiasm for the partnership and the potential to establish a new standard of excellence in psychedelic-assisted therapies for palliative care patients.
iNGENū's role in the partnership is to leverage its experience in conducting clinical trials to design and execute the study. Veronika Simic, Senior Clinical Project Manager at iNGENū, highlighted the significance of the collaboration in advancing the development of evidence-based treatments for Adjustment Disorder in oncology patients.
Fluence's mission is to equip healthcare professionals with the necessary skills for effective psychedelic therapy through comprehensive, evidence-based training. The organization has educated over 7,000 practitioners and is recognized for its ethical and interactive training methods. iNGENū, on the other hand, is dedicated to facilitating access to high-quality clinical research and operates as a full-service CRO with a network of research professionals.
Psyence Biomedical Ltd is committed to an evidence-based approach to developing safe and effective psychedelic therapeutics for a range of mental health disorders, with an initial focus on palliative care. The company's commitment to innovation and patient-centered biopharmaceuticals is reflected in its partnership approach and the development of a nature-derived psilocybin candidate for the treatment of Adjustment Disorder in cancer patients.