Psyence Group’s NASDAQ Listed Associate, Psyence Biomedical, Receives Human Research Ethics Committee (HREC) Approval to Initiate Phase IIb Study  

NEW YORK, March 12, 2024 (GLOBE NEWSWIRE) — Psyence Group Inc (“Psyence Group“) (CSE: PSYG), a clinical-stage life science biotechnology company pioneering the use of nature-derived psilocybin in mental health and wellbeing, is pleased to announce that its NASDAQ listed associate, Psyence Biomedical Ltd (NASDAQ:PBM) (“PBM” or “Psyence Biomed“) has received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia. The study will be conducted through PBM’s subsidiary, Psyence Australia (Pty) Ltd (“Psyence Australia“) and 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. According to a news release issued by PBM on March 6, 2024, an estimated 56.8 million people worldwide require palliative care annually, with a substantial number of these patients exhibiting a high burden of psychosocial distress after diagnosis.

The news release goes on to state that Adjustment Disorder is a serious condition affecting around 19% of patients with a life-limiting diagnosis. It severely impacts the quality of life for patients, their families and caregivers, and regularly ranks among the top seven psychiatric diagnoses in the world, according to the World Health Organization.   

Psyence Australia has partnered with a noted psychedelic Contract Research Organization (CRO), iNGENū Pty Ltd (“iNGENū“), to design and execute the clinical trial. iNGENū is an Australia-based, globally focused CRO with extensive experience working in psychedelic pharmaceutical drug research and development.

Upon the close of the previously announced business combination with Newcourt Acquisition Corp, effective January 25, 2024, Psyence Group was issued 5,000,000 common shares in PBM, equal to approximately a 37% interest in PBM.

“We are very pleased with the progress being made by PBM, and the recent approval of its Phase IIb study in palliative care by HREC shows that the management team has maintained the momentum of the Psyence Biomed business following the implementation of the Business Combination and is executing on its strategy,” said Jody Aufrichtig, Executive Chairman of the board of Psyence Group.

Dr. Neil Maresky, Psyence Biomedical Ltd Chief Executive Officer is quoted as saying: “[PBM is] very pleased to have received HREC’s approval to initiate this clinical trial in the field of palliative care that, if successful, will enable [PBM] to seek a paradigm shift in the treatment of patients with life-limiting illnesses, improving quality life and elevating the standard of care,” going on to say that: “It is a privilege to conduct this pioneering research with nature-derived psilocybin that may result in significant improvements in patients’ lives. HREC approval represents an important milestone for [PBM], and we can now proceed to initiate this important trial as expeditiously as possible.”

The double-blind, placebo-controlled Phase IIb study will test three doses (25mg, 10mg and 1mg) of nature-derived psilocybin in 84 patients in conjunction with psychotherapy. The primary endpoint is change in HAM-A (Hamilton Anxiety Rating Scale), a widely used tool to measure anxiety severity, over time.

“Developing therapies such as psilocybin assisted psychotherapy, which may reduce patients’ stress and anxiety and result in better quality of life as they navigate a cancer diagnosis, can be very impactful. The current management of Adjustment Disorder in palliative care has a low rate of success in addressing all symptoms, indicating that a significant unmet medical need persists. With psilocybin assisted psychotherapy, there is an opportunity to both improve patient quality of life while also reducing health care costs associated with palliative care,” Dr. Maresky added.

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

PBM anticipates enrolling the first patient in Q2 2024 and expects the primary endpoint results to be available in 2025.

About Psyence Group and Psyence Biomed:

Psyence Group is a life science biotechnology company listed on the Canadian Securities Exchange (CSE: PSYG), with a focus on natural psychedelics. Psyence Biomed (now trading on the NASDAQ under the ticker symbol “PBM”) 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 divisions, Psyence Production and Psyence Function, and minority stake in Psyence Biomed (the former therapeutics division), anchor an international collaboration, with operations in Canada, the United Kingdom, Southern Africa, Australia and a presence in the United States.

Learn more at www.psyence.com and on Twitter, Instagram and LinkedIn.

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