Psyence Biomed to Export Psilocybin to Australia, Updates on Phase IIb Trial

Psyence Biomedical Ltd., a company listed on Nasdaq (PBM), has recently announced the successful export of its nature-derived psilocybin to Australia. This development is a significant step towards initiating a Phase IIb clinical trial aimed at evaluating psilocybin as a potential treatment for Adjustment Disorder in patients with advanced cancer in a palliative care setting.

Psyence Biomedical had previously established partnerships with Fluence, a leader in psychedelic therapy research and training, and iNGENū CRO Pty Ltd (iNGENū), an Australian clinical research organization. These collaborations are crucial for the upcoming study. Following a recent visit to Australia by the company's leadership to meet with partners and assess trial sites, the company is now ready to commence the trial, having successfully exported the psilocybin drug candidate, PEX010, supplied by Filament Health.

Dr. Clive Ward-Able, Medical Director of Psyence Biomed, expressed confidence in the progress made over the past few months. He noted that with the successful export of PEX010, efforts would now focus on the efficient enrollment of patients for the study. The trial will be a randomized, double-blind, placebo-controlled study involving 84 patients. It will compare two therapeutic doses of psilocybin (10mg and 25mg) against a low-dose comparator (1mg), combined with psychotherapy. The objective is to conduct a well-designed study that, if successful, could lead to future late-stage trials.

The company also provided an update on its commercial licensing agreement with Filament Health. Initially, this agreement covered the supply of PEX010 for Phase III studies in Adjustment Disorder and granted Psyence Biomed worldwide rights to commercialize the drug within palliative care. However, after further negotiations, both parties have agreed to terminate the commercial licensing agreement. Despite this, Filament Health will continue to supply PEX010 for the upcoming Phase IIb trial.

Psyence Biomed is actively evaluating new supply and license agreements with licensed suppliers in the United Kingdom and North America. The company intends to announce further updates as these agreements are finalized. Dr. Neil Maresky, CEO of Psyence Biomed, highlighted the progress made in identifying alternative suppliers of non-synthetic psilocybin, reaffirming that this change will have minimal impact on their development timelines. The company's goal remains to introduce a novel therapy for Adjustment Disorder in the palliative care context as efficiently as possible.

Psyence Biomedical Ltd. is the first biotechnology company focused on developing botanical psilocybin-based medicines to be listed on Nasdaq. The company's name, "Psyence," reflects its commitment to combining psychedelics and science to develop evidence-based, nature-derived psychedelic therapeutics aimed at treating various mental health disorders, with an initial focus on palliative care.