NEW YORK, July 26, 2024 (GLOBE NEWSWIRE) -- Psyence Group Inc ("Psyence Group") (CSE: PSYG), a life science biotechnology company pioneering the use of nature-derived psilocybin in mental health and wellbeing, is pleased to announce that its NASDAQ-listed associate, Psyence Biomedical Ltd (NASDAQ: PBM) ("PBM" or "Psyence Biomed"), has announced the export of nature-derived psilocybin to Australia and provided an update on its upcoming Phase IIb clinical trial.
According to a news release issued by Psyence Biomed on Wednesday, July 24, 2024, it has made substantial progress in preparing for its Phase IIb study, and reported that all parties responsible for the carrying out of the study are poised to initiate the study imminently. The successful export of Psyence Biomed’s drug candidate, PEX010, is expected to activate the enrollment of patients for the study.
"We are very pleased with the progress being made by Psyence Biomed, and look forward to further updates on patient enrollment and trial initiation," said Jody Aufrichtig, Executive Chairman of the board of Psyence Group.
The randomized, double-blind, placebo-controlled Phase IIb study will evaluate two therapeutic doses of nature-derived psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 84 patients in conjunction with psychotherapy. Psyence Biomed states in this news release that it "aims to execute an efficient yet rigorously designed study that, if successful, would best support advancement into future late-stage studies."
Psyence Group currently holds 5,000,000 common shares in Psyence Biomed, equal to an approximate interest of 30.25%.
Filament Health Commercial Licensing Agreement Update
As previously disclosed, Psyence Group and Filament Health Corp. ("Filament") concluded an IP licensing agreement ("R&D Licensing Agreement"), relating to the supply and licensing of PEX010 by Filament in connection with phase II clinical trials evaluating nature derived psilocybin as a potential treatment for Adjustment Disorder within the context of palliative care. All right, title and interest in and to the R&D Licensing Agreement and the license contemplated therein has been assigned from Psyence Group to Psyence Biomed so that Psyence Biomed may pursue the execution of its upcoming Phase IIb clinical trial.
As further previously disclosed, Psyence Group and Filament Health Corp. ("Filament") also concluded a binding term sheet (the "Commercial Term Sheet"), relating to the commercial licensing of PEX010, which remained subject to the terms of a definitive agreement. Following further discussions, the parties have mutually agreed to terminate the Commercial Term Sheet. Filament will continue to support the supply of PEX010 for Psyence Biomed's upcoming Phase IIb trial while Psyence Biomed is evaluating two exclusive supply and license agreements with duly licensed suppliers operating in the United Kingdom and North America. Psyence Biomed states in its news release that it "intends to provide further updates on such agreements as they are executed" but notes that "there can be no guarantees that such agreements will be finalized."
According to Dr. Neil Maresky, CEO of Psyence Biomed, the company has made "significant progress identifying alternative suppliers of nature-derived, non-synthetic psilocybin for use in subsequent clinical studies", and that the above change "should have minimal impact on [Psyence Biomed's] internal development timelines for [its] Phase IIb program".More information on Psyence Biomed's upcoming Phase IIb clinical trial can be found at: 12624000449538p.
About Psyence Group and Psyence Biomed:
Psyence Group is a life science biotechnology company listed on the Canadian Securities Exchange (CSE: PSYG), with a focus on natural psychedelics. Psyence Biomed is the world’s first life science biotechnology company traded on the Nasdaq (NASDAQ: PBM) that is focused on the development of botanical (nature derived, or non-synthetic) psilocybin-based psychedelic medicines, and works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name "Psyence" combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research.
Informed by nature and guided by science, Psyence Group has built and operates one of the world’s first federally licensed commercial psilocybin mushroom cultivation and production facilities in Southern Africa. Our team brings international experience in both business and science and includes experts in mycology, neurology, palliative care, and drug development. We work to develop advanced natural psilocybin products for clinical research and development.