Psyence Group Inc. (CSE:PSYG / OTCQB: PSYGE), a life science biotechnology company pioneering the use of natural psilocybin in mental health and well-being, is pleased to announce that its newly incorporated wholly owned Australian subsidiary, Psyence Australia Pty Ltd, has partnered with iNGENū Pty Ltd (iNGENū) to conduct Psyence’s previously announced clinical trial in palliative care. iNGENū is an Australian based, globally focused Contract Research Organization (CRO) with extensive experience working in the psychedelic pharmaceutical drug development and clinical research industry.
iNGENū 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.
“We are delighted to be in a position to initiate Psyence’s first clinical trial in palliative care and are working tirelessly to execute the initial phases of setting up this study. By partnering with iNGENu, we will benefit from their experience as a leading psychedelic CRO. In addition, the Australian Federal Government’s Research & Development tax incentive program, which can provide up to a 43.5% rebate on our research and development expenses in Australia, makes it a very cost-effective endeavour”.
Dr. Neil Maresky, Chief Executive Officer of Psyence.
“It is a privilege to serve as the chosen CRO for Psyence and be part of their investigative team using psychedelic assisted psychotherapy in such an innovative fashion,” Dr. Sud Agarwal, Chief Executive Officer of iNGENū. “Being able to help this vulnerable patient group who are suffering major mental health issues secondary to their cancer diagnosis, will be very rewarding professionally.”
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.
About Psyence Group, Inc.
Psyence is a life science biotechnology company, with a focus on natural psychedelics. The Psyence Biomed Division works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name “Psyence” combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research. Informed by nature and guided by science, we built and operate one of the world’s first federally licensed commercial psilocybin mushroom cultivation and production facilities in Southern Africa. Our team brings international experience in both business and science and includes experts in mycology, neurology, palliative care, and drug development. We work to develop advanced natural psilocybin products for clinical research and development. Our key divisions, Psyence Production, Psyence Therapeutics and Psyence Function, anchor an international collaboration, with operations in Canada, the United Kingdom, Southern Africa, and a presence in the United States and Australia.i
About iNGENū CRO Pty Ltd
iNGENū is a globally focused Contract Research Organization working exclusively in the cannabinoid and psychedelic space. Our core values: subject matter expertise – globally unmatched expertise in psychedelic drug development; client-centric culture – a highly transparent and collaborative style of partnering with sponsors; and an agile and lean approach to drug development. The Australian advantage is the ability to perform high quality (FDA-eligible) clinical trials prior to opening an IND, accessing 43.5% research and development rebate from the Australian Government, and rapid start-up of clinical trials in under 12 weeks.