Biomind Labs Welcomes U.S. Policy Shift as a Historic Milestone for Psychedelic Therapies
Biomind Labs responds positively to U.S. government's progressive stance on psychedelic therapies, marked by the nomination of a new Health Secretary supportive of innovative mental health solutions. The company's drug candidate BMND08 showed 100% efficacy in Phase II trials, achieving remission from depression, anxiety, and stress by week 5. The company plans to pursue Breakthrough Therapy Designation with the FDA. Biomind's portfolio includes several drug candidates: Triptax™ (FDA IND clearance), BMND01 (DMT), BMND07 (5-MeO-DMT), BMND02 (nasal), and BMND08 (sublingual formulation).
Biomind Labs reagisce positivamente alla posizione progressista del governo degli Stati Uniti sulle terapie psicoattive, evidenziata dalla nomina di un nuovo Segretario della Salute favorevole alle soluzioni innovative per la salute mentale. Il candidato farmaco dell'azienda BMND08 ha mostrato un'efficacia del 100% negli studi di Fase II, raggiungendo la remissione da depressione, ansia e stress entro la quinta settimana. L'azienda pianifica di perseguire la Designazione di Terapia Innovativa con la FDA. Il portafoglio di Biomind include diversi candidati farmaco: Triptax™ (approvazione IND della FDA), BMND01 (DMT), BMND07 (5-MeO-DMT), BMND02 (nasale) e BMND08 (formulazione sublinguale).
Biomind Labs responde positivamente a la postura progresista del gobierno de EE. UU. sobre las terapias psicodélicas, marcada por la nominación de un nuevo Secretario de Salud que apoya soluciones innovadoras para la salud mental. El candidato a medicamento de la compañía BMND08 mostró una eficacia del 100% en los ensayos de Fase II, logrando la remisión de la depresión, la ansiedad y el estrés en la semana 5. La compañía planea buscar la Designación de Terapia Innovadora con la FDA. El portafolio de Biomind incluye varios candidatos a medicamentos: Triptax™ (autorización IND de la FDA), BMND01 (DMT), BMND07 (5-MeO-DMT), BMND02 (nasal) y BMND08 (formulación sublingual).
바이오마인드 랩스는 혁신적인 정신 건강 솔루션을 지지하는 새로운 보건부 장관의 임명으로 표시된 미국 정부의 진보적인 입장에 긍정적으로 대응하고 있습니다. 회사의 약물 후보 BMND08은 2상 시험에서 100%의 효능을 보였으며, 5주차에 우울증, 불안 및 스트레스에서 완化에 도달했습니다. 이 회사는 FDA와 함께 혁신적인 치료법 지정을 추구할 계획입니다. 바이오마인드의 포트폴리오에는 여러 약물 후보가 포함되어 있습니다: Triptax™ (FDA IND 승인), BMND01 (DMT), BMND07 (5-MeO-DMT), BMND02 (비강), BMND08 (설하 제형).
Biomind Labs répond positivement à la position progressiste du gouvernement américain sur les thérapies psychédéliques, marquée par la nomination d'un nouveau Secrétaire à la Santé favorable à des solutions innovantes en santé mentale. Le candidat médicament de l'entreprise BMND08 a montré une efficacité de 100% lors des essais de Phase II, atteignant la rémission de la dépression, de l'anxiété et du stress en 5 semaines. L'entreprise prévoit de demander le statut de thérapie innovante auprès de la FDA. Le portefeuille de Biomind comprend plusieurs candidats médicaments : Triptax™ (approbation IND de la FDA), BMND01 (DMT), BMND07 (5-MeO-DMT), BMND02 (nasal) et BMND08 (formulation sublinguale).
Biomind Labs reagiert positiv auf die progressive Haltung der US-Regierung zu psychedelischen Therapien, die durch die Ernennung eines neuen Gesundheitsministers gekennzeichnet ist, der innovative Lösungen für die psychische Gesundheit unterstützt. Der Arzneimittelkandidat des Unternehmens BMND08 zeigte eine Wirksamkeit von 100% in Phase-II-Studien und erreichte innerhalb von 5 Wochen eine Remission von Depressionen, Angstzuständen und Stress. Das Unternehmen plant, den Durchbruch-Therapie-Status bei der FDA zu beantragen. Biominds Portfolio umfasst mehrere Arzneimittelkandidaten: Triptax™ (FDA IND Genehmigung), BMND01 (DMT), BMND07 (5-MeO-DMT), BMND02 (nasal) und BMND08 (sublinguale Formulierung).
- BMND08 achieved 100% efficacy in Phase II clinical trials
- FDA granted IND clearance for Triptax™
- Successfully developed pharmaceutical-grade synthesis process for BMND07
- Multiple drug delivery formats in development (inhaled, intramuscular, nasal, sublingual)
- None.
TORONTO, ON / ACCESSWIRE / November 20, 2024 / Biomind Labs Inc. (" Biomind " or the " Company ") (CBOE:BMND)(OTC PINK:BMNDF)(FRA:3XI) , a leading biotech company at the forefront of next-generation pharmaceuticals addressing the root causes of neurological disorders, is encouraged by the U.S. government's progressive stance on the psychedelic industry. The administration's decision to nominate a new Health Secretary with a history of supporting innovative mental health solutions marks a pivotal moment for the advancement of psychedelic-based therapies.
The Company is optimistic that this policy shift will open new avenues for greater recognition and regulatory support of groundbreaking therapies, including its proprietary drug candidate BMND08 . In a Phase II clinical trial, BMND08 demonstrated remarkable efficacy, with
Alejandro Antalich, CEO of Biomind Labs, commented: "The nomination of a Health Secretary in the U.S. who recognizes the transformative potential of psychedelic-based therapies and demonstrates a clear commitment to supporting their development marks a historic milestone for our industry. At Biomind, we are proud to be at the forefront of this movement with our groundbreaking 5-MeO-DMT-based candidate, BMND08 , which has the potential to revolutionize treatment options for neuropsychiatric disorders. We remain focused in our discussions with the FDA to advance BMND08, aiming for regulatory breakthroughs that will deliver life-changing therapies to those who need them most."
Biomind Labs remains committed to driving innovation in psychedelic-based treatments while working closely with regulators and policymakers to create a sustainable and impactful future for mental health therapies:
On November 14, 2022, the U.S. Food and Drug Administration ("FDA") granted Investigational New Drug ("IND") clearance for the Company's New Chemical Entity ("NCE"), Triptax™ .
BMND01 (DMT): Optimized extraction and purification from natural sources under Good Laboratory Practices ("GLP"), with advanced inhaled and intramuscular formulations for efficient, precise, and patient-friendly delivery.
BMND07 (5-MeO-DMT): Successfully developed a pharmaceutical-grade organic synthesis process, ensuring high-purity Active Pharmaceutical Ingredient (API).
BMND02 (5-MeO-DMT Nasal): Introduced a thermosensitive nasal gel for enhanced mucosal permeation, supported by a pending patent application.
BMND08 (5-MeO-DMT Sublingual): Developed a cost-effective, scalable, and non-invasive sublingual formulation.
About Biomind Labs Inc.
Biomind Labs is a biotech research and development company focused on transforming biomedical sciences knowledge into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs is developing novel pharmaceutical formulations of key endogenous substances which are occurring in the human body and an organic compound that includes many neurotransmitters for treating a wide range of therapeutic indications. Biomind Labs is dedicated to providing patients with access to affordable and contemporary treatments.
For more information, please contact:
Biomind Labs Inc.
Alejandro Antalich
Chief Executive Officer
Email: info@biomindlabs.com
Tel: + 598 97 702500
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This press release contains statements that constitute "forward-looking information" ("forward-looking information") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this document include, among others, statements relating to the Company's ability to scientifically harness the medicinal power of certain molecules to treat patients suffering from neurological and psychiatric disorders, future research and development in various therapeutic areas, the anticipated results and potential of the Company's future trials, the ability to obtain regulatory approvals, the marketability of the Company's products, ability to source raw materials in the formulation of products, ability to raise capital, and the Company's plan to engineer proprietary drug development platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.
By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors and risks include, among others: (a) the Company may require additional financing from time to time in order to continue its operations which may not be available when needed or on acceptable terms and conditions acceptable; (b) compliance with extensive government regulation; (c) domestic and foreign laws and regulations could adversely affect the Company's business and results of operations; (d) fluctuations in securities markets; (e) adverse changes in the public perception of tryptamine-based treatments and phenethylamine-based therapies; (f) fluctuations in general macroeconomic conditions; (g) expectations regarding the size of the targeted market; (h) the ability of the Company to successfully achieve its business objectives; (i) plans for growth; (j) political, social and environmental uncertainties; (k) employee relations; (l) the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and (m) the risk factors set out in the Company's annual information form for the year ended December 31, 2023, which is available under the Company's Issuer profile on SEDAR+ at www.sedarplus.ca . Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release.
The Company makes no medical, treatment or health benefit claims about the Company's proposed products. The United States Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding tryptamine-based treatments or phenethylamine-based therapies. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of tryptamines, tryptamine derivatives or phenethylamines, phenethylamine derivatives can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not yet completed commercial 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 commercial 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.
The forward-looking information contained in this news release represents the expectations of the Company as of the date of this news release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. The Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.
The CBOE Exchange Inc. has neither approved nor disapproved the contents of this news release and is not responsible for the adequacy and accuracy of the contents herein.
SOURCE: Biomind Labs Inc.
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FAQ
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