VANCOUVER, British Columbia, Jan. 08, 2023 (GLOBE NEWSWIRE) — Psyence Group Inc (CSE:PSYG | OTCQB: PSYGF), a life science biotechnology company pioneering the use of natural psilocybin in mental health and well-being, today announced that it has signed a Letter of Intent (LOI) with Contract Research Organisation (CRO) iNGENū CRO Pty Ltd (iNGENū) to execute Psyence’s strategy of market leading clinical development of psilocybin within palliative care. iNGENū is a globally focused CRO with extensive experience in working in the psychedelic pharmaceutical drug development and clinical research industry. iNGENū 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.
“We are intent on progressing our clinical research strategy as expeditiously as possible and Australia’s highly supportive clinical research and regulatory environment has made it a key early research destination for Psyence,” said Dr. Neil Maresky, Chief Executive Officer of Psyence. “Engaging an experienced and trusted CRO is critical to the success of our mission and we are delighted to sign this LOI with iNGENū in this regard.”
Dr. Sud Agarwal, Chief Executive Officer of iNGENū commented “our team is pleased that Psyence has contracted iNGENū with their clinical development needs and we look forward to working together to design and conduct trials with our partner investigators here in Australia. We are impressed with both their clinical team and their wider team driving this exciting program at the forefront of palliative care.”
The Phase IIb study will be carried out by iNGENū 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.