Psyence Biomed Announces Phase IIb Clinical Trial Listing on the Australian New Zealand Clinical Trials Registry (ANZCTR)

NEW YORK, April 17, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that details of its upcoming Phase IIb clinical trial of nature-derived psilocybin in patients diagnosed with Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context has been listed on the Australian New Zealand Clinical Trials Registry (“ANZCTR”), under registration number 12624000449538p.

The randomized, double-blind, placebo-controlled Phase IIb study will test three doses (25mg, 10mg and 1mg) of nature-derived psilocybin in 84 patients in conjunction with psychotherapy. Psyence Biomed anticipates enrolling the first subject in the second quarter of 2024 and expects the primary endpoint results to be available in 2025.

“The listing for our Phase IIb clinical trial on ANZCTR reflects the meaningful progress that we are making in the development of a safe and effective psilocybin-based treatment for the roughly 19% of patients who suffer from Adjustment Disorder following an advanced cancer diagnosis¹, with a focus on Palliative Care,” said Neil Maresky, MD, Chief Executive Officer of Psyence Biomed. “Working with our partners, Fluence and iNGENū, we look forward to screening the first patients for this important trial in the coming weeks and efficiently advancing it through to topline data next year.”

More information can be found on the ANZCTR website: 12624000449538p.

About Psyence Biomed

Psyence Biomedical Ltd., a corporation organized under the laws of Ontario, Canada, is the world’s first life science biotechnology company traded on The Nasdaq Stock Market LLC (“Nasdaq”) (Nasdaq:PBM) that is focused on the development of botanical (nature derived, or non-synthetic) psilocybin-based psychedelic medicines. 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, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Psyence Biomed is initially focused on mental health disorders in the context of Palliative Care.