Optimi Health & ATMA Receive No Objection Letter from Health Canada for Phase 2 Clinical Trial
Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) has received a No Objection Letter from Health Canada for a Phase 2 clinical trial using their GMP natural psilocybin extract capsules. The trial, conducted with ATMA Journey Centers, will study Major Depressive Disorder in 200 frontline mental healthcare workers affected by COVID-19. This approval marks a significant step in Optimi's clinical validation efforts in Canada, complementing their ongoing Real World Evidence collection in Australia.
The study aims to assess the safety, efficacy, and therapeutic potential of psilocybin-assisted psychotherapy. It will also explore how psilocybin might enhance the professional capacities of healthcare workers, particularly in psychedelic therapy. This research could provide important insights into new treatment options for those most affected by the pandemic's mental health challenges.
Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) ha ricevuto una Lettera di Nessuna Obiezione da Health Canada per un studio clinico di fase 2 che utilizza le loro capsule di estratto naturale di psilocibina GMP. Lo studio, condotto con ATMA Journey Centers, esaminerà il Disturbo Depressivo Maggiore in 200 operatori sanitari di prima linea colpiti da COVID-19. Questa approvazione segna un passo significativo negli sforzi di validazione clinica di Optimi in Canada, integrando la loro continua raccolta di Evidenze nel Mondo Reale in Australia.
Lo studio mira a valutare la sicurezza, l'efficacia e il potenziale terapeutico della psicoterapia assistita da psilocibina. Esplorerà anche come la psilocibina possa migliorare le capacità professionali degli operatori sanitari, in particolare nella terapia psichedelica. Questa ricerca potrebbe fornire importanti informazioni su nuove opzioni di trattamento per coloro che sono stati maggiormente colpiti dalle sfide di salute mentale della pandemia.
Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) ha recibido una carta de No Objeciones de Health Canada para un ensayo clínico de fase 2 utilizando sus cápsulas de extracto natural de psilocibina GMP. El ensayo, realizado con ATMA Journey Centers, estudiará el Trastorno Depresivo Mayor en 200 trabajadores de la salud de primera línea afectados por COVID-19. Esta aprobación marca un paso significativo en los esfuerzos de validación clínica de Optimi en Canadá, complementando su continua recolección de Evidencias del Mundo Real en Australia.
El estudio tiene como objetivo evaluar la seguridad, eficacia y potencial terapéutico de la psicoterapia asistida por psilocibina. También explorará cómo la psilocibina podría mejorar las capacidades profesionales de los trabajadores de la salud, especialmente en la terapia psicodélica. Esta investigación podría proporcionar información importante sobre nuevas opciones de tratamiento para aquellos más afectados por los desafíos de salud mental de la pandemia.
Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF)는 건강 캐나다로부터 GMP 천연 사이로시빈 추출물 캡슐을 사용한 2상 임상 시험에 대한 반대 없음 서한을 받았습니다. ATMA Journey Centers와 함께 진행되는 이 시험은 COVID-19 영향을 받은 200명의 최전선 정신 건강 관리 노동자에 대한 주요 우울 장애를 연구할 것입니다. 이 승인으로 Optimi의 캐나다에서의 임상 검증 노력이 중요한 진전을 이루고 있으며, 호주에서 진행 중인 실제 증거 수집과 상 complement 하고 있습니다.
이 연구는 사이로시빈 보조 심리 치료의 안전성, 효능 및 치료 잠재력을 평가하는 것을 목표로 합니다. 또한 사이로시빈이 정신 치료에서 건강 관리 직원의 전문 능력을 어떻게 향상시킬 수 있는지 탐구할 것입니다. 이 연구는 팬데믹으로 인한 정신 건강 문제에 가장 큰 영향을 받은 사람들을 위한 새로운 치료 옵션에 대한 중요한 통찰력을 제공할 수 있습니다.
Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) a reçu une Lettre de Non-Objection de la part de Santé Canada pour un essai clinique de phase 2 utilisant leurs capsules d'extrait naturel de psilocybine GMP. L'essai, mené en collaboration avec ATMA Journey Centers, étudiera le trouble dépressif majeur chez 200 travailleurs de la santé de première ligne affectés par la COVID-19. Cette approbation marque une étape significative dans les efforts de validation clinique d'Optimi au Canada, complétant leur collecte continue de preuves du monde réel en Australie.
L'étude vise à évaluer la safety, l'efficacité et le potentiel thérapeutique de la psychothérapie assistée par psilocybine. Elle explorera également comment la psilocybine pourrait améliorer les capacités professionnelles des travailleurs de la santé, en particulier dans la thérapie psychédélique. Cette recherche pourrait fournir des informations importantes sur de nouvelles options de traitement pour les personnes les plus touchées par les défis de santé mentale causés par la pandémie.
Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) hat von Health Canada ein No Objection Letter für eine Phase-2-Studie erhalten, die ihre GMP-natürlichen Psilocybin-Extraktkapseln verwendet. Die Studie, die in Zusammenarbeit mit ATMA Journey Centers durchgeführt wird, untersucht Major Depressive Disorder bei 200 Frontline-Mental-Gesundheitsmitarbeitern, die von COVID-19 betroffen sind. Diese Genehmigung ist ein bedeutender Schritt in den klinischen Validierungsanstrengungen von Optimi in Kanada und ergänzt ihre laufende Sammlung von Real-World-Evidenz in Australien.
Die Studie zielt darauf ab, die Sicherheit, Wirksamkeit und therapeutisches Potenzial von psilocybin-unterstützter Psychotherapie zu bewerten. Sie wird auch untersuchen, wie Psilocybin die beruflichen Fähigkeiten von Gesundheitsarbeitern, insbesondere in der psychedelischen Therapie, verbessern könnte. Diese Forschung könnte wichtige Einblicke in neue Behandlungsoptionen für die am stärksten von den psychischen Herausforderungen der Pandemie betroffenen Personen bieten.
- Received Health Canada approval for Phase 2 clinical trial
- Collaboration with ATMA Journey Centers for the study
- Potential to gather comprehensive data from clinical trials and real-world evidence
- Unique position as a GMP-compliant, end-to-end manufacturer in the psychedelics industry
- Focus on treating frontline mental healthcare workers affected by COVID-19
- None.
Trial to study Major Depressive Disorder using Optimi's GMP natural psilocybin capsules in conjunction with therapy
Vancouver, British Columbia--(Newsfile Corp. - August 28, 2024) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a GMP-compliant, Health Canada-licensed manufacturer of psychedelics pharmaceuticals specializing in botanical psilocybin and MDMA, is pleased to announce the receipt of a No Objection Letter (NOL) from Health Canada. This authorization permits the use of the Company's GMP natural psilocybin extract capsules in a Phase 2 clinical trial, conducted in collaboration with ATMA Journey Centers LTD. ("ATMA").
Advancing Clinical Validation in Canada
The approval to initiate this Phase 2 clinical trial represents a pivotal moment in the clinical development of Optimi's GMP natural psilocybin extract capsules. Building on its established status as a treatment option for patients with treatment-resistant depression (TRD) in Australia, this trial will provide a rigorous evaluation of the capsules in 200 participants within a controlled clinical environment in Canada. The study is scheduled to commence in the coming months, and is expected to yield valuable insights that will contribute to the broader understanding of psilocybin as a potential therapeutic option within the Canadian healthcare system.
Pathway to Further Clinical Development
This Phase 2 trial, focused within Canada, is designed to assess the safety, efficacy, and therapeutic potential of Optimi's psilocybin extract capsules. The results of this study will be crucial in advancing the clinical understanding of natural psilocybin's role in treating mental health conditions, with the ultimate goal of integrating this therapy into clinical practice through official registration of the drug in Canada.
"We are deeply grateful to Health Canada for approving our GMP psilocybin extract for this pivotal Phase 2 trial," said Bill Ciprick, CEO of Optimi. "This approval not only propels our clinical validation efforts in Canada but also underscores our unique position in the global psychedelics industry. We are thrilled to be partnering with ATMA on this groundbreaking study, which complements our ongoing collection of Real World Evidence (RWE) from patients in Australia."
Ciprick added that Optimi is now among the very few companies worldwide that can both clinically validate a drug in a controlled setting and gather real-world data across diverse patient populations. "As a GMP-compliant, end-to-end manufacturer, we are uniquely positioned to access and leverage this comprehensive data set, ensuring our products meet the highest standards of quality and efficacy on a global scale."
Unique Focus on Frontline Mental Healthcare Workers
A distinguishing feature of this trial is its focus on improving the mental health of frontline mental healthcare workers. The Phase II study, titled A Phase II Study Assessing the Efficacy of Psilocybin-assisted Psychotherapy when Administered to Frontline Mental Healthcare Workers Suffering from Major Depressive Disorder related to COVID-19, will evaluate the effectiveness of psilocybin in treating COVID-19-related Major Depressive Disorder (MDD) in 200 frontline healthcare workers. The trial will also explore the potential of psilocybin to enhance the professional capacities of these workers, particularly in the context of psychedelic therapy.
Background and Importance of the Study
Psychological illness imposes a significant global burden, with one in five adults experiencing mental health disorders annually, and nearly a third facing such issues in their lifetime.1 Major Depressive Disorder (MDD) is particularly prevalent and is expected to become the leading cause of disease burden by 2030.2 The COVID-19 pandemic has exacerbated these challenges, especially for frontline healthcare workers who have endured increased stress, hazardous conditions, and stigmatization. These factors have led to heightened mental health concerns, often resulting in long-term consequences like burnout, anxiety, and depression.3
Frontline healthcare workers, already disproportionately affected by mental health issues compared to the general population, have seen these challenges worsen due to the severe circumstances of the pandemic. Occupational burnout, characterized by emotional exhaustion, detachment, and decreased job satisfaction, contributes to serious outcomes such as PTSD, increased suicide rates, and reduced quality of care. Traditional pharmacotherapies for mental health disorders often come with limitations, including variable efficacy and undesirable side effects, highlighting the need for novel treatments with better safety profiles and more rapid, sustained effects.4
Psilocybin, a compound derived from certain mushrooms, has shown promise as a potential breakthrough treatment for conditions like MDD, treatment-resistant depression, and anxiety. Recent studies have demonstrated its efficacy and safety, leading to growing interest in its therapeutic potential. This trial will investigate psilocybin's effectiveness in treating COVID-19-related MDD in frontline mental healthcare workers, while also exploring its impact on enhancing their professional capacities, particularly in the realm of psychedelic therapy. This research could provide crucial insights into new treatment options for those most affected by the pandemic's mental health challenges.
About Optimi Health Corp.
Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) 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, top-tier GMP-grade products and APIs to researchers, drug developers, and authorized patients worldwide. Optimi's facilities in Princeton, British Columbia, are purpose-built to develop proprietary formulations under strict GACP and GMP conditions, ensuring unparalleled quality and reliability. The Company is committed to being the most trusted supplier of safe psychedelic drug candidates globally.
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.
Contact Information
Optimi Health Corp.
For more information about Optimi Health Corp., please contact:
Bill Ciprick, CEO
Telephone: (778) 761-4551
For media inquiries, please contact:
Andrea Mestrovic
Email: Andrea@weareverypolite.com
For investor inquiries, please contact:
Michael Kydd
Email: investors@optimihealth.ca
For more information, please visit www.optimihealth.ca.
1 National Institute of Mental Health
2 Nature
3 National Library of Medicine
4 Ibid
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/221268
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