Psyence Biomed Announces Export of Nature-Derived Psilocybin to Australia and Provides Update on Upcoming Phase IIb Trial
Psyence Biomedical (Nasdaq: PBM) has announced the successful export of nature-derived psilocybin to Australia for its upcoming Phase IIb clinical trial. The trial will evaluate psilocybin as a potential treatment for Adjustment Disorder in advanced cancer patients in Palliative Care. The study, supported by partnerships with Fluence and iNGENū, is set to begin shortly.
The randomized, double-blind, placebo-controlled trial will assess two therapeutic doses (10mg, 25mg) against a 1mg active comparator in 84 patients. Psyence Biomed has terminated its commercial licensing agreement with Filament Health but is evaluating new supply agreements. The company remains committed to its development timeline and introducing a novel therapy efficiently.
Psyence Biomedical (Nasdaq: PBM) ha annunciato con successo l'esportazione di psilocibina derivata dalla natura in Australia per il suo prossimo trial clinico di Fase IIb. Il trial valuterà la psilocibina come possibile trattamento per il Disturbo da Adjustamento in pazienti affetti da cancro avanzato in cure palliative. Lo studio, supportato da partnership con Fluence e iNGENū, è in programma di iniziare a breve.
Il trial randomizzato, in doppio cieco e controllato con placebo, valuterà due dosi terapeutiche (10mg, 25mg) confrontate con un comparatore attivo di 1mg su 84 pazienti. Psyence Biomed ha interrotto il suo accordo di licenza commerciale con Filament Health, ma sta valutando nuovi accordi di fornitura. L'azienda rimane impegnata nella sua tempistica di sviluppo e nell'introduzione di una nuova terapia in modo efficiente.
Psyence Biomedical (Nasdaq: PBM) ha anunciado con éxito la exportación de psilocibina derivada de la naturaleza a Australia para su próximo ensayo clínico de Fase IIb. El ensayo evaluará la psilocibina como un posible tratamiento para el Trastorno de Ajuste en pacientes con cáncer avanzado en Cuidados Paliativos. El estudio, respaldado por asociaciones con Fluence e iNGENū, se espera que comience pronto.
El ensayo, que es aleatorio, doble ciego y controlado por placebo, evaluará dos dosis terapéuticas (10mg, 25mg) frente a un comparador activo de 1mg en 84 pacientes. Psyence Biomed ha rescindido su acuerdo de licencia comercial con Filament Health, pero está evaluando nuevos acuerdos de suministro. La empresa sigue comprometida con su cronograma de desarrollo y con la introducción eficiente de una nueva terapia.
사이언스 바이오메디컬(Psyence Biomedical) (Nasdaq: PBM)는 호주에서 자연 유래의 실로시빈을 성공적으로 수출했다고 발표했습니다. 이는 곧 시작될 예정인 2b상 임상시험의 일환입니다. 이 시험은 말기 암 환자의 완화 치료에 있어 실로시빈이 적응장애 치료에 대한 잠재적인 치료제로 평가될 것입니다. Fluence 및 iNGENū와의 파트너십으로 지원받는 이 연구는 곧 시작될 예정입니다.
무작위 이중 맹검 위약 대조 시험은 84명의 환자를 대상으로 두 가지 치료 용량(10mg, 25mg)을 1mg의 활성 비교군과 비교할 것입니다. Psyence Biomed는 Filament Health와의 상업 라이센스 계약을 종료했지만 새로운 공급 계약을 평가하고 있습니다. 이 회사는 개발 일정을 준수하며 효율적으로 새로운 치료법을 도입하기 위해 최선을 다하고 있습니다.
Psyence Biomedical (Nasdaq: PBM) a annoncé l'exportation réussie de psilocybine d'origine naturelle vers l'Australie pour son prochain essai clinique de Phase IIb. L'essai évaluera la psilocybine comme un potentiel traitement pour le trouble d'ajustement chez les patients atteints de cancer avancé en soins palliatifs. L'étude, soutenue par des partenariats avec Fluence et iNGENū, devrait débuter prochainement.
L'essai, randomisé, en double aveugle et contrôlé par placebo, évaluera deux doses thérapeutiques (10mg, 25mg) par rapport à un comparateur actif de 1mg chez 84 patients. Psyence Biomed a résilié son accord de licence commerciale avec Filament Health, mais évalue de nouveaux contrats de fourniture. L'entreprise reste engagée dans son calendrier de développement et vise à introduire efficacement une nouvelle thérapie.
Psyence Biomedical (Nasdaq: PBM) hat den erfolgreichen Export von naturgewonnener Psilocybin nach Australien für seine bevorstehende Phase IIb-Studie angekündigt. Die Studie wird Psilocybin als potenzielle Behandlung für Anpassungsstörung bei fortgeschrittenen Krebspatienten in Palliativpflege evaluieren. Die Studie, die durch Partnerschaften mit Fluence und iNGENū unterstützt wird, soll in Kürze beginnen.
Die randomisierte, doppelblinde, placebo-kontrollierte Studie wird zwei therapeutische Dosen (10mg, 25mg) im Vergleich zu einem aktiven Vergleichspräparat von 1mg bei 84 Patienten bewerten. Psyence Biomed hat seine kommerzielle Lizenzvereinbarung mit Filament Health beendet, prüft jedoch neue Lieferverträge. Das Unternehmen bleibt seinem Zeitplan für die Entwicklung verpflichtet und strebt eine effiziente Einführung einer neuartigen Therapie an.
- Successful export of nature-derived psilocybin (PEX010) to Australia for Phase IIb trial
- Phase IIb trial set to begin imminently, evaluating psilocybin for Adjustment Disorder in advanced cancer patients
- Partnerships established with Fluence and iNGENū to support the study
- Evaluating two exclusive supply and license agreements with UK and North American suppliers
- Termination of commercial licensing agreement with Filament Health for PEX010 supply and commercialization rights
- Uncertainty in securing new supply agreements for future clinical studies
Insights
The export of nature-derived psilocybin to Australia marks a significant milestone for Psyence Biomed's upcoming Phase IIb clinical trial. This development, coupled with the company's partnerships with Fluence and iNGENū, positions them to initiate the study promptly. The trial's focus on Adjustment Disorder in advanced cancer patients within Palliative Care is particularly noteworthy.
The study design appears robust, with 84 patients randomized to receive either 10mg, 25mg, or a 1mg active low-dose comparator of psilocybin in conjunction with psychotherapy. This approach allows for dose-response evaluation and placebo control, enhancing the trial's scientific validity.
However, the termination of the commercial licensing agreement with Filament Health raises some concerns. While Filament will continue to supply PEX010 for the Phase IIb trial, Psyence Biomed's search for new suppliers for future studies introduces an element of uncertainty. The company's ability to secure reliable, long-term suppliers will be important for maintaining development timelines and ensuring consistent product quality across trials.
From a research perspective, the use of nature-derived psilocybin, as opposed to synthetic versions, is intriguing. This approach may offer potential benefits in terms of the entourage effect, but it also presents challenges in standardization and scalability that will need to be addressed as the company moves towards larger, late-stage trials.
The news presents a mixed bag for Psyence Biomed's financial outlook. On the positive side, the progress towards initiating the Phase IIb trial is encouraging. Clinical trials represent significant milestones for biotech companies, often serving as catalysts for stock movement and potential partnerships or investments.
However, the termination of the commercial licensing agreement with Filament Health is a notable setback. This agreement would have covered supply for pivotal Phase III studies and granted worldwide commercialization rights for PEX010 (25 mg) in Palliative Care. The loss of these rights could impact Psyence Biomed's long-term revenue potential and market positioning.
The company's pursuit of alternative suppliers introduces both opportunities and risks. While it may lead to more favorable terms, it also adds uncertainty and potential delays. Investors should closely monitor the company's ability to secure new agreements, as these will be important for future clinical development and commercialization plans.
From a financial perspective, the company's cash position and burn rate will be critical factors to watch. Clinical trials are expensive and any delays or complications in securing suppliers could impact the company's financial runway. Without specific financial figures provided, it's difficult to assess the company's current financial health, but investors should be prepared for potential future capital raises to fund ongoing research and development.
Trial projected to be initiated shortly following receipt of drug product by trial sites
NEW YORK, July 24, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today announced the export of nature-derived psilocybin to Australia and provided an update on its upcoming Phase IIb clinical trial evaluating nature-derived psilocybin as a potential treatment for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context.
The Company previously announced that it had 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. Following a recent site visit by Psyence Biomed leadership to partners and trial sites in Australia, the Company is preparing to initiate the study shortly following the recent successful export of drug candidate, PEX010, from its current supplier, Filament Health.
“Over the past several months, we have made substantial progress preparing for our Phase IIb study, and following my recent site visit to Australia, I am pleased to report that all parties, including Psyence and our partners, Fluence and iNGENū, are poised to initiate the study imminently,” said Dr. Clive Ward-Able, Medical Director of Psyence Biomed. “With the successful export of PEX010, we now plan to focus on the efficient enrollment of patients into this important study.”
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 84 patients in conjunction with psychotherapy. Psyence aims to execute an efficient yet rigorously designed study that, if successful, would best support advancement into future late-stage studies.
More information on the study can be found at: 12624000449538p.
Filament Health Commercial Licensing Agreement Update
Psyence Biomed’s commercial licensing agreement with Filament Health, which covered supply of PEX010 for pivotal Phase III studies in Adjustment Disorder and also granted Psyence Biomed the worldwide right to commercialize PEX010 (25 mg) within the context of Palliative Care, remained subject to further negotiations between the parties and the completion of a subsequent definitive agreement within a predefined time period.
Following further discussions, both parties have mutually agreed to terminate the commercial licensing agreement. Filament Health will continue to support the supply PEX010 for the upcoming Phase IIb trial, as previously announced. Psyence Biomed is evaluating two exclusive supply and license agreements with duly licensed suppliers operating in the United Kingdom and North America. The Company intends to provide further updates on such agreements as they are executed. However, there can be no guarantees that such agreements will be finalized.
“We have made significant progress identifying alternative suppliers of nature-derived, non-synthetic psilocybin for use in subsequent clinical studies, and we look forward to securing a partner that can support our needs over the long-term,” stated Dr. Neil Maresky, CEO of Psyence Biomed. “Importantly, this change should have minimal impact on our internal development timelines for our Phase IIb program, and we remain committed to introducing a novel therapy for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context as efficiently as possible.”
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company focused on the development of botanical (nature-derived, or 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. The Company 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, the anticipated delivery of the drug candidate, PEX010, in Australia, 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 the anticipated shipment of the drug candidate, PEX010, will be successfully delivered to Australia, Psyence Australia Pty Ltd. (“Psyence Australia”), the Company’s Australian subsidiary, will receive all such regulatory and other approvals as may be required to implement the clinical trial, that patient recruitment will be successful in accordance with the expected timelines, and that contract negotiations with alternative suppliers of drug product will be successful.
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 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 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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