Optimi Health to Supply GMP-Certified Psilocybin for Psyence Biomed's Phase IIb Palliative Care Trial
Optimi Health Corp (OPTHF) has entered binding agreements with Psyence Biomedical to become their exclusive supplier of GMP-certified psilocybin for clinical research and drug development programs. The partnership focuses on Psyence's Phase IIb trial for Adjustment Disorder and future commercialization initiatives in Palliative Care.
Optimi will provide GMP-certified, nature-derived psilocybin extract capsules and Chemistry, Manufacturing, and Control (CMC) support for regulatory submissions. This ensures Psyence's access to consistent psilocybin supply for current programs, Phase III trials, and potential commercialization. The agreement supports Psyence's Investigational New Drug (IND) application with the FDA.
Optimi Health Corp (OPTHF) ha stipulato accordi vincolanti con Psyence Biomedical per diventare il loro fornitore esclusivo di psilocibina certificata GMP per la ricerca clinica e i programmi di sviluppo farmaceutico. La partnership si concentra sulla fase IIb della sperimentazione per il Disturbo da Regolazione e sulle future iniziative di commercializzazione nella Cura Palliativa.
Optimi fornirà capsule di estratto di psilocibina di origine naturale e certificate GMP, insieme al supporto per la Chimica, Produzione e Controllo (CMC) per le presentazioni regolatorie. Questo garantisce a Psyence un accesso costante alla fornitura di psilocibina per i programmi attuali, le sperimentazioni di fase III e una potenziale commercializzazione. L'accordo supporta la domanda di Nuovo Farmaco Sperimentale (IND) di Psyence presso la FDA.
Optimi Health Corp (OPTHF) ha firmado acuerdos vinculantes con Psyence Biomedical para convertirse en su proveedor exclusivo de psilocibina certificada GMP para la investigación clínica y los programas de desarrollo de medicamentos. La asociación se centra en el ensayo de Fase IIb para el Trastorno por Ajuste y futuras iniciativas de comercialización en Cuidados Paliativos.
Optimi proporcionará cápsulas de extracto de psilocibina de origen natural y certificadas GMP, junto con apoyo en Química, Fabricación y Control (CMC) para las presentaciones regulatorias. Esto asegura a Psyence un acceso constante al suministro de psilocibina para los programas actuales, ensayos de Fase III y potencial comercialización. El acuerdo respalda la solicitud de Nuevo Medicamento en Investigación (IND) de Psyence ante la FDA.
Optimi Health Corp (OPTHF)는 Psyence Biomedical와 임상 연구 및 약물 개발 프로그램을 위한 GMP 인증된 실로시빈의 독점 공급자가 되기 위한 구속력 있는 계약을 체결했습니다. 이 파트너십은 조정 장애를 위한 2상 IIb 시험과 완화 치료의 미래 상업화 이니셔티브에 초점을 맞추고 있습니다.
Optimi는 GMP 인증을 받은 자연 유래 실로시빈 추출 캡슐과 규제 제출을 위한 화학, 제조 및 품질 관리(CMC) 지원을 제공할 것입니다. 이는 Psyence가 현재 프로그램, 3상 시험 및 잠재적 상업화를 위한 일관된 실로시빈 공급에 접근할 수 있도록 보장합니다. 이 계약은 FDA에 대한 Psyence의 연구신약(IND) 신청을 지원합니다.
Optimi Health Corp (OPTHF) a conclu des accords contraignants avec Psyence Biomedical pour devenir leur fournisseur exclusif de psilocybine certifiée GMP pour la recherche clinique et les programmes de développement de médicaments. Le partenariat se concentre sur l'
Optimi fournira des capsules d'extrait de psilocybine d'origine naturelle et certifiées GMP, ainsi qu'un soutien en Chimie, Fabrication et Contrôle (CMC) pour les soumissions réglementaires. Cela garantit à Psyence un accès constant à un approvisionnement en psilocybine pour les programmes actuels, les essais de Phase III et une commercialisation potentielle. L'accord soutient la demande de Médicament Expérimental (IND) de Psyence auprès de la FDA.
Optimi Health Corp (OPTHF) hat verbindliche Vereinbarungen mit Psyence Biomedical getroffen, um deren exklusiver Lieferant von GMP-zertifiziertem Psilocybin für klinische Forschung und Arzneimittelentwicklungsprogramme zu werden. Die Partnerschaft konzentriert sich auf die Phase IIb Studie für Anpassungsstörungen und künftige Kommerzialisierungsinitiativen in der Palliativmedizin.
Optimi wird GMP-zertifizierte, naturbasierte Psilocybin-Extraktkapseln sowie Unterstützung in Chemie, Herstellung und Kontrolle (CMC) für regulatorische Einreichungen bereitstellen. Dadurch wird Psyence ein konsistenter Zugang zu Psilocybin-Versorgungen für aktuelle Programme, Phase III-Studien und potenzielle Kommerzialisierung garantiert. Die Vereinbarung unterstützt den Antrag auf ein Investigational New Drug (IND) bei der FDA durch Psyence.
- Secured exclusive supplier agreement for Psyence's worldwide Palliative Care programs
- Partnership extends to Phase IIb, Phase III trials and potential commercialization
- Agreement includes CMC support for regulatory submissions and IND application
- None.
Agreement Supports Phase IIb and Future Phase III Trial Development,
Addressing Critical Needs in Palliative Care Using Optimi's Natural Psilocybin Extract
Vancouver, British Columbia--(Newsfile Corp. - December 17, 2024) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian manufacturer of GMP-certified, naturally-derived psilocybin and MDMA, has entered into binding agreements with Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed"). Under the terms of the agreement, Psyence Biomed will exclusively source GMP-certified psilocybin from Optimi for its clinical research and drug development programs, including its Phase IIb trial for Adjustment Disorder and commercialization initiatives for FDA-approved uses in Palliative Care.
As part of the agreements, Optimi will supply GMP-certified, nature-derived psilocybin extract capsules and provide comprehensive Chemistry, Manufacturing, and Control ("CMC") support to facilitate regulatory submissions. This collaboration guarantees Psyence Biomed's access to a consistent GMP supply of natural psilocybin for its current and future clinical programs, including preparations for Phase III registrational trials and potential commercialization. Psyence Biomed is also advancing its Investigational New Drug (IND) application process with the U.S. Food and Drug Administration (FDA), leveraging Optimi's psilocybin to meet strict regulatory requirements.
"This partnership highlights Optimi's leadership in the production of high-quality psilocybin drug candidates for clinical trials," said Dane Stevens, Chief Executive Officer of Optimi. "As Psyence Biomed's exclusive supplier, we are proud to support their important work addressing significant unmet mental health needs in Palliative Care. We are excited to see our natural psilocybin extract further validated in a clinical setting and take another step toward commercial use with Psyence Biomed."
Dr. Neil Maresky, Chief Executive Officer of Psyence Biomed, added: "Optimi's psilocybin extract capsules align with the strict quality and regulatory standards we require for our clinical programs and drug development. This partnership ensures we have the resources necessary to advance our Phase IIb trial, pursue our IND registration, and prepare for the next stages of global research initiatives and commercialization efforts."
Key Agreement Highlights
Phase IIb Clinical Trial Focus: Psyence Biomed's ongoing Phase IIb clinical trial is evaluating psilocybin for Adjustment Disorder in Palliative Care, addressing significant unmet mental health needs. The trial is being conducted in Australia through Psyence Biomed's Australian subsidiary, Psyence Australia Pty Ltd.
Exclusive Relationship: Psyence Biomed is required to exclusively source GMP-certified psilocybin for its planned world-wide Palliative Care programs from Optimi.
CMC and IND Support: Optimi will provide CMC documentation to support Psyence Biomed's IND application and clinical progress toward Phase III studies and commercialization in jurisdictions in which the proposed drug candidate has been approved for use in the Palliative Care setting.
About Optimi Health Corp.
Optimi Health Corp. is a leading psychedelics pharmaceutical Manufacturer licensed by Health Canada. Specializing in controlled substances such as botanical psilocybin and MDMA, Optimi is dedicated to supplying safe, GMP-grade products and APIs to researchers, drug developers, and authorized patients worldwide. Optimi's facilities in Princeton, British Columbia, are designed for the development of proprietary formulations under strict GACP and GMP standards, ensuring unparalleled quality and reliability. The Company is committed to being the most trusted supplier of safe psychedelic drug candidates globally.
About Psyence Biomed Ltd.
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'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.
On behalf of the Board of Directors,
OPTIMI HEALTH CORP.
JJ Wilson, Chair of the Board
For more information, please contact the Company at:
Telephone: (778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions, or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward-looking statements. These statements may involve estimates, assumptions, and uncertainties that could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct, and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Optimi undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/234088
FAQ
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