Psyence Group Inc. announced that its newly incorporated wholly owned Australian subsidiary, Psyence Australia Pty Ltd, has partnered with iNGEN Pty Ltd. (iNGEN) to conduct Psyence's previously announced clinical trial in palliative care. iNGEN is an Australian based, globally focused Contract Research Organization with extensive experience working in the psychedelic pharmaceutical drug development and clinical research industry. iNGEN will be responsible for jointly designing Psyence's Phase IIb clinical trial, using a natural psilocybin drug candidate PEX010, in the palliative care setting.

The trial will be carried out in accordance with the requirements of the Therapeutic Goods Administration of the Commonwealth of Australia as well as other international guidelines that relate to clinical investigations and the conduct of clinical research. Psyence's Phase IIb study is a planned randomised, placebo-controlled, double-blind study. It will evaluate the use of psilocybin assisted psychotherapy vs psychotherapy alone.

It will use FDA- recommended primary endpoints to test natural psilocybin (PEX010) in over 75 patients with adjustment disorder due to a recent terminal cancer diagnosis. PEX010 (25mg) is standardized to provide 25 mg of psilocybin per oral capsule and has previously received authorization from the FDA and Health Canada to enter into phase 1 and phase 2 human clinical trials. Upon successful completion of the study, Psyence aspires to conduct a multinational Phase III registrational study.