Psyence (PBM) Goes Down Under with Export of Psilocybin to Australia While Phase 2b Study Progresses
The PRISM Psychedelics Index leader Psyence Biomedical Ltd. (PBM) is up over 50% today on the announcement regarding its successful export of nature-derived psilocybin to Australia and has provided an update on its forthcoming Phase 2b clinical trial. This trial will evaluate nature-derived psilocybin as a potential treatment for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care setting.
Previously, Psyence Biomed entered partnerships with Fluence, a leader in professional education for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization, to support this study. Following a recent visit by Psyence Biomed’s leadership to partners and trial sites in Australia, the company is now ready to commence the study, having successfully exported the drug candidate, PEX010, from its supplier, Filament Health.
This randomized, double-blind, placebo-controlled Phase IIb study will involve 84 patients and will evaluate two therapeutic doses of nature-derived psilocybin (10mg and 25mg) against an active low-dose comparator (1mg) in conjunction with psychotherapy. Psyence aims to conduct an efficient, yet rigorously designed study that, if successful, would support future late-stage studies.
Additionally, Psyence Biomed’s commercial licensing agreement with Filament Health, which included the supply of PEX010 for pivotal Phase III studies and the global right to commercialize PEX010 (25 mg) in Palliative Care, was subject to further negotiations. However, both parties have now mutually agreed to terminate the commercial licensing agreement. Filament Health will continue to supply PEX010 for the upcoming Phase IIb trial.
Psyence Biomed is currently evaluating two exclusive supply and license agreements with licensed suppliers in the United Kingdom and North America. The Company will provide further updates as these agreements are finalized, though there is no guarantee that such agreements will be concluded.
