South African entrepreneurs have launched one of the world’s most cutting edge therepeutics group, Psyence, which is now gaining major traction in psychedelic medicine. The Toronto-listed firm, which has a psychedelics production license in Lesotho, is now launching clinical trials in Australia.
South African business visionary Jody Aufrichtig was a cannabis pioneer back in the day with Daddy Can in Lesotho and has since taken his universe to a whole new level.
Besides being behind the development of Amazon’s new office park in Cape Town, the UCT graduate also successfully listed psychedelics company, Psyence on the Toronto Stock Exchange in Canada and secured the first African psychedelics licence from Lesotho.
Now things are ramping up since a consortium led by the late Sol Kerzner’s son Brendon took up an initial private share placement of CAD $1,2 m late last year and a further $3 million CAD was raised in a second tranche of shares released in December 2023 with a view to raising money for psychedelic clinical trials. Psyence has since concluded a deal with Nasdaq listed Newcourt which will give it access to further funding with the backing of former FNB CEO Michael Jordaan.
Psyence earlier this year concluded the first exports of psychedelic medicine out of southern Africa. Hemp entrepreneur Tony Budden is Psyence’s chief strategy officer and oversaw the successful export of psychedelics from Lesotho to the UK in January 2023.
Now Psyence is moving up a notch to conduct the clinical trials that are to take place in Australia.
South African entrepreneur Dr Neil Maresky is CEO of Psyence. He recently announced the launch of an Australian subsidiary, Psyence Australia Pty Ltd which has partnered with with iNGENū Pty Ltd (iNGENū) to conduct a psychedelics clinical trial around 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.
The trials follow a deal done in December 2023 between Psyence and Filament, a pioneer in the use of natural psilocybin in mental health and well-being.
On 15 December 2022 Psyence and Filament announced the conclusion of a royalty-bearing, worldwide commercial licensing agreement. The agreement grants Psyence the worldwide right to commercialize Filament’s natural psilocybin drug candidate, PEX010 (25 mg), within the context of palliative care to study indications including opioid tapering and alcohol use disorder.
According to a Psyence press release then: “Filament will receive milestone payments of up to $3 million over the course of Psyence’s clinical development and marketing authorizations achieved by Psyence, as well as a percentage of future net sales in the low double digits.”
Benjamin Lightburn, Chief Executive Officer of Filament said at the time“ “Palliative care is a complex and under-examined area of study, and Psyence is leading the way with their use of natural psilocybin to treat associated indications. We are thrilled to expand our partnership with Psyence and look forward to the advancement of our drug candidate in this important field.”
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,” said Dr Maresky, “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”.
“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 in its own words:
Psyence is a life science biotechnology company listed on the Canadian Securities Exchange (CSE: PSYG) and quoted on the OTCQB (OTCQB: PSYGF), 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.