New collaboration on psilocybin-assisted psychotherapy trial for Adjustment Disorder in cancer patients
NEW YORK, April 8, 2024 /PRNewswire-PRWeb/ -- Fluence, a global leader in professional education and training for psychedelic therapy research, announces an exciting partnership with Psyence Australia Pty Ltd. ("Psyence Australia"), a subsidiary of Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed"), the world's first Nasdaq-traded life science biotechnology company developing an FDA-approved botanical (nature-derived, meaning non-synthetic) psilocybin pharmaceutical candidate, and iNGENū 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 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 Psyence Biomed
Psyence Biomed is the world's first life science biotechnology company traded on The Nasdaq Stock Market LLC focused on the development of botanical (nature-derived, meaning 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. Psyence Australia is a subsidiary of Psyence Biomed.
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.
Forward-Looking Statements
This press release includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook," and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, the completion and success of the Phase IIb study, the successful patient enrollment and availability of primary endpoint results in connection with the Phase IIb study, and the success of the partnership with Fluence. These statements are based on various assumptions and on the current expectations of Psyence Biomed's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Psyence Biomed. These forward-looking statements are subject to a number of risks and uncertainties. A more complete discussion of the risks and uncertainties facing Psyence Biomed is contained in the "Risk Factors" section of the proxy statement/prospectus forming a part of the Registration Statement on Form F-4 of Psyence Biomed (File No. 333-273553) filed by Psyence Biomed and other documents of Psyence Biomed filed, or to be filed, with the Securities and Exchange Commission. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Psyence Biomed presently does not know or that Psyence Biomed currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Psyence Biomed's expectations, plans or forecasts of future events and views as of the date hereof. Psyence Biomed anticipates that subsequent events and developments will cause Psyence Biomed's assessments to change. However, while Psyence Biomed may elect to update these forward-looking statements at some point in the future, Psyence Biomed specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Psyence Biomed's assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Media Contact
Brad Burge, Fluence, 1 6508636887, [email protected], https://www.fluencetraining.com
SOURCE Fluence
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