Psyence Biomed Announces Recruitment of Second Clinical Trial Site for Ongoing Phase IIb Clinical Trial of Nature-Derived Psilocybin for Adjustment Disorder in Palliative Care
Psyence Biomed (Nasdaq: PBM) has announced the addition of Empax Center in Perth, Australia as the second trial site for its ongoing Phase IIb clinical trial. The study evaluates nature-derived psilocybin for treating Adjustment Disorder in Palliative Care. The company expects to begin patient recruitment this quarter, with topline data anticipated in the second half of 2025. The trial is supported by partnerships with Fluence and iNGENū CRO. In July, Psyence successfully exported its drug product PEX010 to Australia, and patient screening is set to begin with first subject randomization expected in early December.
Psyence Biomed (Nasdaq: PBM) ha annunciato l'aggiunta dell'Empax Center a Perth, Australia, come secondo sito di sperimentazione per il suo ongoing studio clinico di Fase IIb. Lo studio valuta la psilocibina di origine naturale per il trattamento del Disturbo di Adattamento in Cure Palliative. L'azienda prevede di iniziare il reclutamento dei pazienti in questo trimestre, con i dati preliminari attesi nella seconda metà del 2025. La sperimentazione è supportata da collaborazioni con Fluence e iNGENū CRO. A luglio, Psyence ha esportato con successo il suo prodotto farmaceutico PEX010 in Australia, e la selezione dei pazienti è prevista per iniziare con la randomizzazione del primo soggetto previsto per l'inizio di dicembre.
Psyence Biomed (Nasdaq: PBM) ha anunciado la adición del Empax Center en Perth, Australia, como el segundo sitio de ensayo para su estudio clínico de Fase IIb en curso. El estudio evalúa la psilocibina de origen natural para el tratamiento del Trastorno de Ajuste en Atención Paliativa. La compañía espera comenzar el reclutamiento de pacientes en este trimestre, con datos preliminares anticipados para la segunda mitad de 2025. El ensayo cuenta con el apoyo de asociaciones con Fluence e iNGENū CRO. En julio, Psyence exportó con éxito su producto farmacéutico PEX010 a Australia, y la selección de pacientes comenzará pronto, con la randomización del primer sujeto esperada para principios de diciembre.
Psyence Biomed (Nasdaq: PBM)가 호주 퍼스에 있는 Empax Center를 진행 중인 2상 IIb 임상 시험의 두 번째 시험 장소로 추가한다고 발표했습니다. 이 연구는 자연 유래의 실로시빈을 완화의료에서 조정장애 치료에 대해 평가합니다. 회사는 이번 분기 환자 모집을 시작할 계획이며, 주요 데이터는 2025년 하반기에 예상됩니다. 이 임상 시험은 Fluence 및 iNGENū CRO와의 파트너십으로 지원됩니다. 7월에 Psyence는 자사의 의약품 PEX010을 호주로 성공적으로 수출하였으며, 환자 선별은 곧 시작될 예정이며 첫 번째 피험자의 무작위 배정은 12월 초로 예상됩니다.
Psyence Biomed (Nasdaq: PBM) a annoncé l'ajout du Empax Center à Perth, Australie, comme deuxième site d'essai pour son essai clinique de Phase IIb en cours. L'étude évalue la psilocybine d'origine naturelle pour le traitement du Trouble d'Adaptation en Soins Palliatifs. La société prévoit de commencer le recrutement des patients ce trimestre, avec des données préliminaires attendues dans la deuxième moitié de 2025. L'essai est soutenu par des partenariats avec Fluence et iNGENū CRO. En juillet, Psyence a exporté avec succès son produit médical PEX010 vers l'Australie, et le dépistage des patients devrait commencer prochainement, avec la randomisation du premier sujet prévue pour début décembre.
Psyence Biomed (Nasdaq: PBM) hat die Hinzufügung des Empax Center in Perth, Australien, als zweiten Prüfstandort für die laufende Phase-IIb-Studie bekannt gegeben. Die Studie untersucht die Natur-abgeleitete Psilocybin zur Behandlung von Anpassungsstörungen in der Palliativmedizin. Das Unternehmen plant, in diesem Quartal mit der Rekrutierung von Patienten zu beginnen, wobei erste Ergebnisse für die zweite Hälfte des Jahres 2025 erwartet werden. Die Studie wird durch Partnerschaften mit Fluence und iNGENū CRO unterstützt. Im Juli exportierte Psyence erfolgreich sein Arzneimittel PEX010 nach Australien, und das Screenen von Patienten soll bald beginnen, wobei die Randomisierung des ersten Probanden für Anfang Dezember erwartet wird.
- Addition of specialized mental health facility as second trial site
- On track for patient recruitment and timeline goals
- Successfully exported drug product PEX010 to Australia
- First subject randomization expected in early December
- None.
Insights
The addition of Empax Center as a second trial site for Psyence Biomed's Phase IIb psilocybin study represents a strategic expansion of their clinical trial capabilities. The expertise in psychedelic-assisted therapies and mental health treatments at Empax should enhance patient recruitment efficiency and quality of trial execution.
The trial's timeline projections, with topline data expected in H2 2025, align with industry standards for Phase IIb studies. Key operational milestones have been met, including successful drug export to Australia and partnerships with Fluence and iNGENū CRO. The imminent patient screening and expected first patient randomization in December indicate proper trial progression.
However, investors should note that Phase IIb trials carry inherent risks and success is not guaranteed. The specialized nature of the treatment - psilocybin for adjustment disorder in palliative care - represents both an opportunity in an underserved market and a challenge in trial execution.
Empax Center brings significant expertise in clinical trial execution for mental health and neurological conditions
Psyence Biomed on track to begin recruitment this quarter, and to announce Adjustment Disorder topline data in the second half of 2025
NEW YORK, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed" or the "Company") today announced the recruitment of Perth, Australia-based Empax Center as the second trial site for Psyence’s Biomed ongoing Phase IIb clinical trial of nature-derived psilocybin as a potential treatment for Adjustment Disorder in Palliative Care.
“Having Empax Center as our second clinical trial site adds a cutting-edge facility specializing in mental health treatments, including psychedelic-assisted therapies, and also helps position us to enroll this important study as quickly and efficiently as possible,” stated Dr. Clive Ward-Able, Medical Director of Psyence Biomed. “We look forward to initiating patient treatments soon and working towards topline data in the second half of 2025 that, if positive, will support the initiation of pivotal registrational studies shortly thereafter.”
Michael Winlo, Chief Executive Officer of Empax Centre, added, “We are delighted to support this important psilocybin trial, which promises a significant step forward in providing innovative care for patients facing severe existential distress and an adjustment disorder due to a recent terminal cancer diagnosis. At Empax, we’ve always envisioned our center as a place where patients can access the best available care alongside the most promising new treatments in mental health, and we look forward to supporting this trial and ensuring patients have a positive study experience from the expertise of our highly skilled team and purpose-designed facilities.”
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 Biomed 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 sites will soon commence screening patients, and the first subject is expected to be randomized into the study in early December.
About Empax Center:
Located in Perth, Western Australia, Empax Center is a purpose-built facility dedicated to the safe delivery of emerging treatments for serious mental health conditions. Offering safe, effective, and client-centered comprehensive care, Empax Center is led by a team of experienced mental health professionals, including some of the first authorized prescribers of psychedelic-assisted therapies in Australia, to support both research and client care.
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicines to be listed on Nasdaq. Psyence Biomed is initially working to address the unmet needs of patients who suffer from mental health disorders in the context of Palliative Care. 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, regulatory-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. 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 enrolment of patients at the Empax Center, clinical trial milestones, and obtaining topline data in the second half of 2025. These forward-looking statements are based on a number of assumption the anticipated clinical trial implementation schedule will be adhered to.
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 Biomed'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 maintain the licensing of third-party intellectual property rights and supply of raw materials for future discovery and development of its product candidates; (v) Psyence Biomed’s ability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approved products; (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 (File No. 333 276973) filed with the Securities and Exchange Commission 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.
FAQ
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