Psyence Group Inc. announced that it has signed a Letter of Intent (LOI) with Contract Research Organisation (CRO) iNGENu CRO Pty Ltd. (iNGENu) to execute Psyence's strategy of market leading clinical development of psilocybin within palliative care. iNGENu is a globally focused CRO with extensive experience in working in the psychedelic pharmaceutical drug development and clinical research industry. iNGENu will be responsible for jointly designing the Phase IIb clinical trial to be conducted in Australia, in compliance with global standards.

The LOI centres around Psyence's global development and regulatory strategy of its licensed compound PEX010 in palliative care in Phase II clinical trials. The prospective cooperation and trial would potentially reduce Psyence's timeline for starting a Phase III registrational clinical trial. The Phase IIb study will be carried out by iNGENu after the application process has been completed in Australia.

The planned randomised double-blind study, which will take place in Melbourne, 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. Upon successful completion of the study, Psyence aspires to conduct a multinational Phase III registrational study.