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Psyence Biomed Announces Phase IIb Trial of Psilocybin for Adjustment Disorder in Cancer Patients

• Psyence Biomed has listed its Phase IIb clinical trial on the Australian New Zealand Clinical Trials Registry (ANZCTR). • The trial will evaluate nature-derived psilocybin in 84 patients diagnosed with Adjustment Disorder following advanced cancer diagnosis. • The randomized, double-blind, placebo-controlled study will test three psilocybin doses (25mg, 10mg, and 1mg) combined with psychotherapy. • Psyence Biomed anticipates enrolling the first patient in Q2 2024, with primary endpoint results expected in 2025.

Psyence Biomedical Ltd. has announced the listing of its Phase IIb clinical trial on the Australian New Zealand Clinical Trials Registry (ANZCTR) for evaluating nature-derived psilocybin in patients with Adjustment Disorder following an advanced cancer diagnosis within a palliative care context. The trial, registered under number 12624000449538p, marks a significant step in Psyence Biomed's commitment to developing evidence-based psychedelic medicines.
The Phase IIb study is designed as a randomized, double-blind, placebo-controlled trial involving 84 patients. Participants will receive one of three doses of nature-derived psilocybin (25mg, 10mg, or 1mg) in conjunction with psychotherapy. The trial aims to assess the efficacy and safety of psilocybin in treating Adjustment Disorder, which affects approximately 19% of patients diagnosed with advanced cancer, according to a study in Lancet Oncology.

Trial Design and Objectives

The primary objective of the study is to determine the effectiveness of psilocybin-assisted psychotherapy in alleviating symptoms of Adjustment Disorder in palliative care patients. Secondary endpoints may include assessing changes in mood, anxiety, and overall quality of life. The trial will be conducted in accordance with rigorous scientific standards, ensuring patient safety and data integrity.
According to Neil Maresky, MD, Chief Executive Officer of Psyence Biomed, the ANZCTR listing reflects the company's progress in developing a safe and effective psilocybin-based treatment. Psyence Biomed is collaborating with Fluence and iNGENū on this trial, with plans to begin screening patients in the coming weeks. Topline data is anticipated next year.

Psyence Biomed's Focus on Psychedelic Medicines

Psyence Biomed is focused on developing botanical psilocybin-based psychedelic medicines for mental health disorders, particularly in the context of palliative care. The company emphasizes an evidence-based approach to innovation, aiming to create safe and effective therapeutics for a range of mental health conditions.
The company is traded on The Nasdaq Stock Market LLC (Nasdaq:PBM).
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Reference News

[1]
Psyence Biomed Announces Phase IIb Clinical Trial Listing on the Australian New Zealand Clinical Trials Registry (ANZCTR)
finance.yahoo.com · Apr 17, 2024

Psyence Biomedical Ltd announced its Phase IIb clinical trial for nature-derived psilocybin treatment in patients with A...

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