Psyence Biomedical Will Undertake Psilocybin Clinical Trials For Palliative Care In Australia

Psyence Biomedical Ltd PBM recently announced that its wholly-owned subsidiary, Psyence Australia (Pty) received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia.

The study will examine the use of nature-derived psilocybin as a treatment for Adjustment Disorder due to a recent cancer diagnosis in the palliative care context. Worldwide, an estimated 56.8 million people require palliative care annually, with a substantial number of these patients exhibiting a high burden of psychosocial distress after diagnosis.

Psyence Biomed partnered with Australia-based contract research organization iNGENū Pty Ltd to conduct the clinical trial. 

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The Study

The study will include 84 patients and will test three different doses of psilocybin (25mg, 10mg and 1mg) paired with psychotherapy for a potential reduction of anxiety and stress, in turn bringing better outcomes for patients and lowering healthcare costs. Patient enrollment is planned for the second quarter of 2024, and first results are expected in 2025.

iNGENū CEO, Dr. Sud Agrawal, views the clinical trial as "particularly important," as it explores the potential benefits of psychedelic medicine for a vulnerable group of palliative care patients. In his words, "The opportunity for global impact is substantial.”

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Spinout Deal & Business Restructuring

Upon closing the new business combination, effective Jan. 25, 2024, Psyence Group was issued 5,000,000 common shares (or 37% interest) in PBM. These shares are subject to a trading lock-up period of a minimum of 180 days following closing, subject to a further extension under certain conditions, or a change of control event.

Psyence Group reports that, as a result of the spinout, it has "significantly reduced" its operating costs. Essentially, the full senior executives have now moved to PMB, as follows: Dr. Neil Maresky will serve as CEO (formerly Psyence Group CEO); Dr. Clive Ward-Able as Medical Director (formerly Psyence Group's); and Warwick-Corden Lloyd as CFO (formerly Psyence Group's). 

Psyence Group’s financial manager Adri Botha will act as interim CFO while the search for a new CFO and CEO for Psyence Group continues. 

Additionally, Christopher Bull and Dr. Maresky resigned as members of the Psyence Group board to join the PBM board. Jody Aufrichtig and Alan Friedman will retain their respective board positions with Psyence Group, with Aufrichtig continuing as executive board chairman.

Psyence Group's Extra Step To Reduce Overhead

In parallel to the new Nasdaq-trading spinout business, Psyence Group is also restructuring its non-clinical business through a conditional M&A transaction involving the transfer of three assets to a third-party private company to further its development.

These businesses are Mind Health Ltd (Lesotho), housing the psilocybin cultivation, extraction and production operations in Southern Africa; Psyence UK Group Ltd, engaged in Active Pharmaceutical Ingredient (API) and IP development; and the functional mushroom brand GOODMINDTM. 

The private company would focus on the growing, production and extraction operations and creating an API for commercialization in the R&D and medical markets globally while Psyence Group retains sales and distribution rights for all products and services developed and offered. 

The conditional transaction is set to continue the operation of underlying non-clinical business while substantially reducing Psyence Group's overhead.

Photo courtesy of the Psyence Biomedical team. Left to right: CFO Warwick Corden-Lloyd, founder and board chair Jody Aufrichtig, CEO Dr. Neil Maresky, and chief of global impact Mary-Elizabeth Gifford.