Psyence Biomed Highlights Recent Progress on Active Phase IIb Clinical Trial
Psyence Biomed (Nasdaq: PBM) reports progress on its Phase IIb clinical trial testing nature-derived psilocybin with psychotherapy for Adjustment Disorder in palliative care cancer patients. Two Australian trial sites, Vitalis and EMPAX, have been activated with patient screening underway. The company expects to begin patient randomization in January.
The company has engaged Australian Clinical Trial Network (ACTioN) as their site management organization to implement recruitment strategies through social media and direct communications with physicians, trial sites, and advocacy groups. Therapist training continues at both sites, and additional trial locations are being evaluated. Topline results are expected in the second half of 2025.
Psyence Biomed (Nasdaq: PBM) riporta progressi nel suo studio clinico di Fase IIb che testa la psilocibina derivata dalla natura in combinazione con la psicoterapia per il Disturbo di Adattamento in pazienti oncologici in cure palliative. Sono stati attivati due siti di esperimento in Australia, Vitalis e EMPAX, con lo screening dei pazienti in corso. L'azienda prevede di iniziare la randomizzazione dei pazienti a gennaio.
L'azienda ha ingaggiato Australian Clinical Trial Network (ACTioN) come organizzazione di gestione dei siti per implementare strategie di reclutamento tramite social media e comunicazioni dirette con medici, siti di prova e gruppi di advocacy. La formazione dei terapeuti continua in entrambi i siti e si stanno valutando ulteriori luoghi per il trial. I risultati preliminari sono attesi nella seconda metà del 2025.
Psyence Biomed (Nasdaq: PBM) informa sobre el progreso de su ensayo clínico de Fase IIb que prueba la psilocibina derivada de la naturaleza junto con la psicoterapia para el Trastorno de Adaptación en pacientes con cáncer en cuidados paliativos. Se han activado dos sitios de ensayo en Australia, Vitalis y EMPAX, y se está llevando a cabo el cribado de pacientes. La compañía espera comenzar la randomización de pacientes en enero.
La empresa ha contratado a Australian Clinical Trial Network (ACTioN) como su organización de gestión de sitios para implementar estrategias de reclutamiento a través de redes sociales y comunicaciones directas con médicos, sitios de ensayo y grupos de defensa. La formación de terapeutas continúa en ambos sitios, y se están evaluando ubicaciones adicionales para el ensayo. Se esperan resultados preliminares en la segunda mitad de 2025.
Psyence Biomed (Nasdaq: PBM)는 완화 치료 암 환자의 적응장애를 위한 정신치료와 함께 자연 유래의 실로시빈을 테스트하는 IIb상 임상 시험에서의 진행 상황을 보고합니다. 호주에서 Vitalis와 EMPAX 두 개의 시험 사이트가 활성화 되었으며, 환자 선별이 진행 중입니다. 회사는 1월에 환자 무작위 배정을 시작할 것으로 예상하고 있습니다.
회사는 Australian Clinical Trial Network (ACTioN)를 사이트 관리 조직으로 고용하여 소셜 미디어와 의사, 시험 사이트, 옹호 단체와의 직접 교류를 통해 모집 전략을 시행하고 있습니다. 두 사이트 모두에서 치료사 교육이 계속되고 있으며, 추가적인 시험 장소를 평가하고 있습니다. 초기 결과는 2025년 하반기에 기대되고 있습니다.
Psyence Biomed (Nasdaq: PBM) fait état de ses progrès dans son essai clinique de Phase IIb testant la psilocybine d'origine naturelle avec psychothérapie pour le trouble d'adaptation chez les patients atteints de cancer en soins palliatifs. Deux sites d'essai en Australie, Vitalis et EMPAX, ont été activés et le dépistage des patients est en cours. La société s'attend à commencer la randomisation des patients en janvier.
L'entreprise a engagé Australian Clinical Trial Network (ACTioN) en tant qu'organisation de gestion des sites pour mettre en œuvre des stratégies de recrutement via les réseaux sociaux et des communications directes avec les médecins, les sites d'essai et les groupes de défense. La formation des thérapeutes se poursuit sur les deux sites, et d'autres sites d'essai sont évalués. Les résultats préliminaires sont attendus dans la deuxième moitié de 2025.
Psyence Biomed (Nasdaq: PBM) berichtet über Fortschritte in seiner klinischen Phase-IIb-Studie, die naturbasierte Psilocybin in Kombination mit Psychotherapie zur Behandlung von Anpassungsstörungen bei palliativ betreuten Krebspatienten testet. Zwei australische Prüfstandorte, Vitalis und EMPAX, wurden aktiviert und der Patienten-Screening-Prozess ist im Gange. Das Unternehmen plant, im Januar mit der Randomisierung der Patienten zu beginnen.
Die Firma hat Australian Clinical Trial Network (ACTioN) als ihre Site-Management-Organisation engagiert, um Rekrutierungsstrategien über soziale Medien sowie direkte Kommunikation mit Ärzten, Prüfstandorten und Interessengruppen umzusetzen. Die Schulung der Therapeuten wird an beiden Standorten fortgesetzt, und es werden zusätzliche Prüfstandorte evaluiert. Ergebnisse in der Zusammenfassung werden für die zweite Hälfte von 2025 erwartet.
- Phase IIb trial actively progressing with two sites activated
- Patient screening has commenced with randomization starting January
- Engagement of ACTioN SMO to enhance patient recruitment
- Clear timeline for topline results (H2 2025)
- Trial still in early stages with no patients randomized yet
- to only two active trial sites currently
Insights
The initiation of Phase IIb trials for psilocybin-based treatment represents a modest step forward, though several key uncertainties remain. The engagement of ACTioN SMO may help streamline patient recruitment, but the true value proposition hinges on the topline results expected in H2 2025. The focus on Adjustment Disorder in palliative care represents a specific yet potentially valuable niche, though market size remains unclear.
The trial's design across multiple Australian sites and the systematic approach to patient recruitment through social media and physician outreach suggests a well-structured study methodology. However, investors should note that Phase IIb results, while important, still precede the more important Phase III trials needed for regulatory approval. The timeline to potential commercialization remains lengthy and success in treating adjustment disorder in palliative care patients would represent just one indication in the broader psychedelic medicine landscape.
For a company with a
The company's focus on natural psilocybin differentiates it in the psychedelics space, but investors should consider the competitive landscape and regulatory hurdles. While positive trial results could drive value creation, the extended timeline to H2 2025 for topline results indicates a long runway before potential revenue generation. The stock's current valuation reflects both the opportunity and significant execution risks ahead.
Patient screening underway; first patient expected to be randomized into the study in January
A leading clinical trial site management organization (SMO), Australian Clinical Trial Network (ACTioN), has been engaged to implement patient recruitment and retention strategies
NEW YORK, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed" or the "Company") today highlighted recent progress that has been made with its active Phase IIb clinical trial of nature derived psilocybin, in conjunction with psychotherapy, as a potential treatment for Adjustment Disorder following a life-limiting cancer diagnosis in Palliative Care.
To date, two trial sites in Australia - Vitalis and EMPAX - have been activated, and patient screening has commenced. Psyence Biomed anticipates that the first patients will be randomized into the study in January. Additionally, therapist training is ongoing at both sites. Psyence Biomed is also evaluating additional sites to potentially participate in the trial.
To augment its own patient enrollment initiatives, Psyence Biomed’s contract research organization (CRO), iNGENū CRO, has engaged ACTioN SMO to focus on patient recruitment strategies through social media as well as direct email communications to physicians, potential clinical trial sites and disease state advocacy groups, including in the areas of oncology, primary care and psychiatry. ACTioN SMO is working closely with the activated sites, and the initial outreach to a broad audience has occurred.
Dr. Clive Ward-Able, Medical Director of Psyence Biomed, commented, “In collaboration with iNGENū and ACTioN, we have made substantial progress advancing start-up activities related to our Phase IIb trial, and we are poised to commence patient randomization and treatments shortly after this holiday season. With assistance from the team at ACTioN and their proven patient and provider outreach capabilities, we anticipate that the desired recruitment rate will progress smoothly. We look forward to topline results from this trial in the second half of 2025.”
David Harford, Managing Director of ACTioN, added, “We are proud to support Psyence Biomed’s innovative research into the potential of nature-derived psilocybin as a treatment for Adjustment Disorder in the Palliative Care setting. This study aligns with our mission to foster groundbreaking clinical advancements. At ACTioN, we will focus on patient recruitment and retention strategies, which are critical to the study’s success. We are committed to assisting sites in achieving their recruitment goals and ensuring the study’s smooth execution.”
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 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 advancement of Psyence Biomed's Phase IIb clinical trial and patient recruitment, and the production of topline results from this trial. These forward-looking statements are based on a number of assumptions, including the assumptions that the parties will obtain all such regulatory approvals as may be required to execute on the Phase IIb clinical trial, and that there will not be any unforeseen delays in the implementation schedule of the clinical trial.
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) delays in the implementation schedule of Psyence Biomed's Phase IIb clinical trials; (ii) the ability of Psyence Biomed to execute its obligations in respect of its product development objectives; (iii) changes in applicable laws which may impact drug development, clinical trials and/or the conducting thereof; (iv) Psyence Biomed’s ability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approved products; (v) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vi) 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. 333-282468) filed with the Securities and Exchange Commission on October 10, 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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