Mental health-focused biotechnology company Psyence Group’s wholly owned Australian subsidiary, Psyence Australia, has partnered with Contract Research Organization Ingenu to conduct Psyence’s clinical trials in palliative care.
Ingenu will collaborate in the development of Psyence's Phase IIb clinical trial, which involves the use of a natural psilocybin drug called “PEX010” in a palliative care environment. The trial will follow the standards set by the Therapeutic Goods Administration of Australia, as well as other global protocols related to clinical research and investigations.
This trial aims to compare the use of psilocybin-assisted psychotherapy with psychotherapy alone, using primary endpoints recommended by the FDA. It will involve randomized, double-blind, and placebo-controlled methods. PEX010 is standardized to provide 25mg of psilocybin per capsule and has already been authorized by the FDA and Health Canada for Phase I and II human clinical trials. The trial will involve more than 75 patients diagnosed with adjustment disorder following a recent terminal cancer diagnosis.
Psyence is a life science biotechnology company that specializes in natural psychedelics, particularly in palliative care and the treatment of psychological trauma. The company's Psyence Biomed Division works with natural psilocybin products for this purpose. Psyence has established one of the world's first commercial psilocybin mushroom cultivation and production facilities in South Africa, which is federally licensed. The company is focused on various fields such as mycology, neurology, palliative care, and drug development, and operates internationally with divisions including Psyence Production, Psyence Therapeutics, and Psyence Function. The company has a presence in several countries including Canada, the UK, the US, and Australia.
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