Psyence Biomed Announces Initiation of First Trial Site in Australia for its Phase IIb Study of Nature Derived Psilocybin as a Potential Treatment for Adjustment Disorder in Palliative Care
Psyence Biomedical (Nasdaq: PBM) has announced the successful completion of the first site initiation visit for its Phase IIb study of nature-derived psilocybin as a potential treatment for Adjustment Disorder in Palliative Care. The study will be conducted at an Australian clinical trial site, with patient screening set to begin soon and the first subject expected to be randomized in October 2024.
The randomized, double-blind, placebo-controlled study will evaluate two therapeutic doses of psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 87 patients, in conjunction with psychotherapy. Psyence has partnered with Fluence and iNGENū CRO Pty to support the study. The company anticipates topline data in the second half of 2025, which could potentially lead to the initiation of a Phase III clinical program.
Psyence Biomedical (Nasdaq: PBM) ha annunciato il completamento con successo della prima visita di avvio del sito per il suo studio di Fase IIb sull'uso della psilocibina derivata dalla natura come potenziale trattamento per il Disturbo di Adattamento nella Cura Palliativa. Lo studio sarà condotto in un sito di sperimentazione clinica in Australia, con lo screening dei pazienti che inizierà a breve e il primo soggetto previsto per essere randomizzato in ottobre 2024.
Lo studio, randomizzato, in doppio cieco e controllato con placebo, valuterà due dosi terapeutiche di psilocibina (10mg, 25mg) contro un comparatore attivo a basso dosaggio (1mg) in 87 pazienti, in combinazione con la psicoterapia. Psyence ha stretto una partnership con Fluence e iNGENū CRO Pty per supportare lo studio. L'azienda prevede di avere dati preliminari nella seconda metà del 2025, il che potrebbe potenzialmente portare all'avvio di un programma clinico di Fase III.
Psyence Biomedical (Nasdaq: PBM) ha anunciado la finalización exitosa de la primera visita de inicio del sitio para su estudio de Fase IIb sobre la psilocibina derivada de la naturaleza como un posible tratamiento para el Trastorno de Ajuste en Cuidados Paliativos. El estudio se llevará a cabo en un sitio de ensayo clínico en Australia, con el cribado de pacientes programado para comenzar pronto y el primer sujeto esperado para ser aleatorizado en octubre de 2024.
El estudio, aleatorizado, doble ciego y controlado con placebo, evaluará dos dosis terapéuticas de psilocibina (10mg, 25mg) frente a un comparador activo de baja dosis (1mg) en 87 pacientes, junto con psicoterapia. Psyence se ha asociado con Fluence e iNGENū CRO Pty para apoyar el estudio. La compañía anticipa datos preliminares en la segunda mitad de 2025, lo que podría llevar potencialmente al inicio de un programa clínico de Fase III.
Psyence Biomedical (Nasdaq: PBM)는 자연 유래의 실로시빈을 완화 치료에서의 적응 장애에 대한 잠재적 치료제로 연구하기 위한 2b 단계 연구의 첫 번째 사이트 시작 방문이 성공적으로 완료되었음을 발표했습니다. 이 연구는 호주의 임상 시험 사이트에서 진행되며, 환자 선별 작업이 곧 시작될 예정이며 첫 번째 피험자가 2024년 10월에 무작위로 배정될 것으로 예상됩니다.
무작위 이중 맹검 위약 대조 연구는 87명의 환자를 대상으로 두 가지 치료 용량의 실로시빈(10mg, 25mg)을 저용량 활성 비교 제제(1mg)와 함께 심리 치료와 함께 평가할 것입니다. Psyence는 연구를 지원하기 위해 Fluence 및 iNGENū CRO Pty와 파트너십을 맺었습니다. 회사는 2025년 하반기에는 주요 데이터를 anticip하고 있으며, 이는 잠재적으로 3상 임상 프로그램의 시작으로 이어질 수 있습니다.
Psyence Biomedical (Nasdaq: PBM) a annoncé l'achèvement réussi de la première visite d'initiation de site pour son étude de Phase IIb sur la psilocybine dérivée de la nature comme traitement potentiel pour le trouble de l'ajustement en soins palliatifs. L'étude sera réalisée sur un site d'essai clinique en Australie, avec le dépistage des patients prévu pour commencer bientôt et le premier sujet attendu pour être randomisé en octobre 2024.
L'étude, randomisée, en double aveugle et contrôlée par placebo, évaluera deux doses thérapeutiques de psilocybine (10mg, 25mg) par rapport à un comparateur actif à faible dose (1mg) chez 87 patients, en conjonction avec une psychothérapie. Psyence a établi un partenariat avec Fluence et iNGENū CRO Pty pour soutenir l'étude. La société anticipe des données préliminaires dans la seconde moitié de 2025, ce qui pourrait potentiellement conduire à l'initiation d'un programme clinique de Phase III.
Psyence Biomedical (Nasdaq: PBM) hat den erfolgreichen Abschluss des ersten Standort-Besuchs für seine Phase IIb-Studie zur naturabgeleiteten Psilocybin als potenzielle Behandlung von Anpassungsstörungen in der Palliativversorgung bekannt gegeben. Die Studie wird an einem klinischen Prüfstandort in Australien durchgeführt, wobei die Patientenauswahl bald beginnen soll und der erste Teilnehmer voraussichtlich im Oktober 2024 randomisiert wird.
Die randomisierte, doppelblinde, placebo-kontrollierte Studie wird zwei therapeutische Dosierungen von Psilocybin (10mg, 25mg) im Vergleich zu einem aktiven Niedrigdosis-Comparator (1mg) bei 87 Patienten zusammen mit Psychotherapie evaluieren. Psyence hat sich mit Fluence und iNGENū CRO Pty zusammengeschlossen, um die Studie zu unterstützen. Das Unternehmen erwartet im zweiten Halbjahr 2025 erste Ergebnisse, die möglicherweise zur Initiierung eines Phase-III-Studienprogramms führen könnten.
- Successful completion of first site initiation visit for Phase IIb study
- Patient screening to begin imminently, with first subject randomization expected in October 2024
- Partnerships established with Fluence and iNGENū CRO to support the study
- Successful export of drug product PEX010 to Australia completed in July
- Topline data expected in the second half of 2025
- Potential for initiation of Phase III clinical program if results are positive
- None.
Insights
The initiation of Psyence Biomed's Phase IIb study for nature-derived psilocybin in Adjustment Disorder marks a significant advancement in psychedelic research. This trial, focusing on palliative care patients, addresses a critical unmet need in mental health treatment. The use of nature-derived psilocybin, as opposed to synthetic versions, could potentially offer unique therapeutic benefits or safety profiles.
The study's design - randomized, double-blind and placebo-controlled - adheres to gold standard clinical trial methodology. The inclusion of two therapeutic doses (
Psyence Biomed's progress in their psilocybin clinical trial represents a strategic move in the emerging psychedelic therapeutics market. The company's partnership with Fluence for psychedelic therapy training and iNGENū for clinical research execution demonstrates a comprehensive approach to trial management. The successful export of PEX010 to Australia highlights Psyence's ability to navigate complex regulatory landscapes in psychedelic drug development.
Investors should note that while promising, the psychedelic therapeutics sector is still nascent and faces regulatory hurdles. However, Psyence's focus on Adjustment Disorder in palliative care is a smart niche strategy, potentially offering a faster path to market in a high-need area. If successful, this could position Psyence as a leader in a specific psychedelic application, potentially attracting partnerships or acquisition interest from larger pharmaceutical companies seeking to enter the space.
Patient screening to be initiated imminently; first subject expected to be randomized into the study in October
NEW YORK, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”), a developer of naturally derived psilocybin-based therapeutics, today announced that the first site initiation visit has been successfully completed at the first Australian clinical trial site for the Company’s Phase IIb study of nature derived (non-synthetic) psilocybin as a potential treatment for Adjustment Disorder in the Palliative Care context.
Psyence previously announced that it has entered into partnerships 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 the study. In July, Psyence announced the successful export of the drug product, PEX010, to Australia, which marked a crucial step in preparation for initiation of the study. The affiliated trial site will soon commence screening patients, and the first subject is expected to be randomized into the study in October.
“The imminent activation of the first trial site and patient screening for this trial represents a significant milestone for our company, and a positive step forward for the advancement of psychedelic-based therapeutics generally,” said Dr. Clive Ward-Able, Medical Director of Psyence Biomedical. “Together with our partners, iNGENū and Fluence, we will endeavor to quickly enroll this study, and we look forward to topline data in the back half of next year that, if positive, will support the initiation of a pivotal Phase III clinical program as soon as practicable thereafter.”
“As a leading global contract research organization that has notable experience in the execution of psychedelic clinical trials, we believe psilocybin holds great promise as a treatment for a broad range of mental health conditions with unmet needs,” said iNGENū CRO Senior Clinical Project Manager, Veronika Simic. “We are pleased to partner with Psyence Biomedical as they work to introduce a novel, psilocybin-based treatment to patients suffering from Adjustment Disorder following a life limiting cancer diagnosis in Palliative Care, and we are prepared to advance this rigorously designed study as efficiently as possible.”
The randomized, double-blind, placebo-controlled Phase IIb study will evaluate two therapeutic doses of nature-derived psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 87 patients in conjunction with psychotherapy.
More information on the study can be found at: 12624000449538p.
About Psyence Biomedical
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company focused on the development of botanical (nature-derived and non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. 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 is initially focused on mental health disorders in the context of Palliative Care.
Learn more at www.psyencebiomed.com and on LinkedIn.
Contact Information
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com
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 safety and effectiveness of psilocybin as a treatment option for adjustment disorder within the context of Palliative Care. These forward-looking statements are based on a number of assumptions, including the assumption that that trial site initiation and patient recruitment will be successful in accordance with the expected timelines, and that trial results will support the initiation of Phase III registrational trials.
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 Pty Ltd’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 and supply of raw materials 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 final prospectus filed by the Company with the SEC on August 30, 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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