Psyence Biomed Partners with Fluence and iNGENū CRO to Train Research Therapists for Phase IIb Psilocybin Trial

NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that its Australian subsidiary, Psyence Australia Pty Ltd. (“Psyence Australia”), has entered into a partnership with Fluence, a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support an upcoming Phase llb clinical trial. The trial will explore the efficacy and safety of psilocybin-assisted psychotherapy (PAP) for the treatment of Adjustment Disorder due to a recent cancer diagnosis in the Palliative Care context.

According to Lancet Oncology, Adjustment Disorder affects as many as 19% of patients following a life-limiting cancer diagnosis. With symptoms of depression and anxiety that severely impact quality of life for patients, Adjustment Disorder ranks among the seven most frequent psychiatric disorders diagnosed in the world, according to the World Health Organization (WHO).

Fluence’s highly credentialed and widely published faculty members are recognized as the global experts in professional psychedelic therapy education; psychiatrists, psychologists, psychotherapists, physicians, and nurse practitioners have completed its comprehensive certification programs. Fluence is authorized by the American Psychological Association (APA), the National Association of Social Workers (NASW), and other professional organizations as a provider of professional continuing education for clinicians.

“The success of the clinical trial relies on rigorous, standardized therapist training designed to achieve the highest standard of patient care,” said Elizabeth Nielson, PhD, Fluence co-founder. “The training of expert therapists in the specialized skills of psychedelic treatment, using cutting-edge pedagogy and delivered by experienced research clinicians, is key to the delivery of safe and effective treatment.”

“Fluence brings unparalleled expertise in psychedelic therapy training to the collaboration,” said Clive Ward-Able, MD, Psyence Biomed’s Chief Medical Officer. “We expect that Fluence’s participation in this trial will ensure both quality of care for patients and also significantly contribute to the critical body of research needed to evaluate how best to integrate psychedelic-assisted therapy for cancer patients into the standard of care for palliative medicine.”

“As we work to develop a safe, responsible, FDA-approved nature-derived psilocybin candidate to treat Adjustment Disorder in oncology patients in a Palliative Care context, we welcome this partnership with Fluence,” said Psyence Biomed CEO Neil Maresky, MD. “As a patient-centered biopharmaceutical company, we look forward to deepening our collaboration with Dr. Nielson and her exemplary faculty, and to working with Fluence to create a therapeutic alliance that we hope will set a gold standard of excellence for this Phase llb trial for the Palliative Care patient population, and for the emerging field of nature-derived psychedelic-assisted therapies.”

To design and execute the clinical trial, Psyence Australia is partnering with iNGENū, an Australia-based, globally focused CRO with extensive experience in psychedelic pharmaceutical drug research and development.

“This partnership between Fluence, Psyence Australia, and iNGENū signifies a significant step forward in the Psyence team’s mission to develop safe and effective treatments for Adjustment Disorder in oncology patients within a Palliative Care context,” said iNGENū CRO Senior Clinical Project Manager, Veronika Simic. “Together, we are dedicated to pioneering evidence-based therapies that have the potential to make a profound impact on the lives of patients in need.”

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. Psyence Biomed anticipates enrolling the first subject in the second quarter of 2024 and expects the primary endpoint results to be available in 2025.

About Fluence
Fluence is the global leader in providing comprehensive, evidence-based training in psychedelic therapy and integration to healthcare professionals. With a mission to equip clinicians with the clinical skills and knowledge necessary for effective, evidence-based psychedelic therapy and integration services, Fluence offers ethical, dynamic, interactive training both online and in-person. Since its inception, Fluence has educated over 7,000 practitioners, establishing itself as a frontrunner in psychedelic therapy training for private enterprises and research organizations.

About iNGENū
iNGENū is the FDA-centric Australian CRO championing disruptive, innovative biotech firms globally. iNGENū’s core mission is to create access to high quality clinical research globally by removing financial and other unnecessary barriers. iNGENū is a physician-led, full-service CRO with in-house access to an established network of clinical trial research professionals.

About Psyence Biomed
Psyence Biomedical Ltd., is the world’s first life science biotechnology company traded on the Nasdaq (Ticker:PBM) that is focused on the development of botanical (nature derived, or non-synthetic) psilocybin-based psychedelic medicines. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Psyence Biomed is initially focused on mental health disorders in the context of Palliative Care.

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Forward Looking Statements
This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “believe,” “intend,” “plan,” “projection,” “outlook” or words of similar meaning.

Forward-looking statements in this communication include statements regarding the commencement of the clinical trial referred to in this news release and the anticipated timeframes for the execution of the clinical trial and receipt of trial results. These forward-looking statements are based on a number of assumptions, including the assumption that Psyence Australia will receive all such regulatory and other approvals as may be required to implement the clinical trial, and that patient recruitment will be successful in accordance with the expected timelines.

There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the ability of iNGENū to execute its obligations in respect of the clinical trial; (ii) changes in applicable laws which may impact the clinical trial and/or the conducting thereof; (iii) Psyence Australia’s ability to achieve successful clinical results; (iv) Psyence Biomed’s ability to obtain regulatory approval for its product candidates, and any related restrictions or limitations of any approved products; (v) Psyence Biomed’s ability to obtain licensing of third-party intellectual property rights for future discovery and development of its product candidates; (vi) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on NASDAQ; and (vii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the Registration Statement on Form F-1, initially filed by the Company with the SEC on February 9, 2024 and other documents filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company does not intend to update these forward-looking statements.

The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

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