Quantum Biopharma Announces Signing of an Agreement with a Global Pharmaceutical Contract Research Organization to Prepare an IND (Investigational New Drug) Application Package for Lucid-21-302 (Lucid-MS), A First-In-Class Treatment for Multiple Sclerosis
Quantum BioPharma (NASDAQ: QNTM) has signed an agreement with a global pharmaceutical contract research organization to prepare an Investigational New Drug (IND) application for Lucid-21-302 (Lucid-MS), targeting submission to the FDA in Q4 2025. The successful IND application will enable the company to proceed with Phase 2 trials for multiple sclerosis treatment.
Lucid-21-302 is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action. This patented New Chemical Entity has demonstrated ability in preclinical models to prevent demyelination, a known cause of MS and other neurodegenerative diseases affecting the myelin sheath around nerve fibers.
Quantum BioPharma (NASDAQ: QNTM) ha firmato un accordo con un'organizzazione globale di ricerca contrattuale farmaceutica per preparare una domanda di Nuovo Farmaco Sperimentale (IND) per Lucid-21-302 (Lucid-MS), con l'obiettivo di presentarla alla FDA nel quarto trimestre del 2025. L'approvazione della domanda IND consentirà all'azienda di avviare le prove di Fase 2 per il trattamento della sclerosi multipla.
Lucid-21-302 è un composto neuroprotettivo innovativo, non immunomodulatorio e di prima classe con un meccanismo d'azione unico. Questa Nuova Entità Chimica brevettata ha dimostrato, in modelli preclinici, la capacità di prevenire la demielinizzazione, una causa nota della sclerosi multipla e di altre malattie neurodegenerative che colpiscono la guaina mielinica intorno alle fibre nervose.
Quantum BioPharma (NASDAQ: QNTM) ha firmado un acuerdo con una organización global de investigación farmacéutica por contrato para preparar una solicitud de Nuevo Fármaco en Investigación (IND) para Lucid-21-302 (Lucid-MS), con la intención de presentarla a la FDA en el cuarto trimestre de 2025. La aprobación exitosa de la solicitud IND permitirá a la compañía avanzar con los ensayos de Fase 2 para el tratamiento de la esclerosis múltiple.
Lucid-21-302 es un compuesto neuroprotector innovador, no inmunomodulador y de primera clase con un mecanismo de acción único. Esta Nueva Entidad Química patentada ha demostrado en modelos preclínicos la capacidad de prevenir la desmielinización, una causa conocida de la EM y otras enfermedades neurodegenerativas que afectan la vaina de mielina alrededor de las fibras nerviosas.
Quantum BioPharma (NASDAQ: QNTM)는 글로벌 제약 계약 연구 기관과 협약을 체결하여 Lucid-21-302 (Lucid-MS)의 임상시험계획(IND) 신청서를 준비하고 있으며, 2025년 4분기에 FDA 제출을 목표로 하고 있습니다. IND 신청서가 승인되면 회사는 다발성 경화증 치료를 위한 2상 임상시험을 진행할 수 있게 됩니다.
Lucid-21-302는 독특한 작용 기전을 가진 최초의 비면역조절 신경보호 화합물입니다. 이 특허받은 새로운 화학 물질은 전임상 모델에서 신경 섬유를 둘러싼 미엘린 수초의 손상인 탈수초화를 예방하는 능력을 입증했으며, 이는 다발성 경화증 및 기타 신경퇴행성 질환의 원인으로 알려져 있습니다.
Quantum BioPharma (NASDAQ : QNTM) a signé un accord avec une organisation mondiale de recherche sous contrat pharmaceutique pour préparer une demande de nouveau médicament expérimental (IND) pour Lucid-21-302 (Lucid-MS), visant une soumission à la FDA au quatrième trimestre 2025. L'approbation de cette demande IND permettra à la société de lancer des essais de phase 2 pour le traitement de la sclérose en plaques.
Lucid-21-302 est un composé neuroprotecteur innovant, non immunomodulateur et de première classe avec un mécanisme d'action unique. Cette nouvelle entité chimique brevetée a démontré dans des modèles précliniques sa capacité à prévenir la démyélinisation, une cause reconnue de la sclérose en plaques et d'autres maladies neurodégénératives affectant la gaine de myéline autour des fibres nerveuses.
Quantum BioPharma (NASDAQ: QNTM) hat eine Vereinbarung mit einer globalen pharmazeutischen Auftragsforschungsorganisation unterzeichnet, um einen Investigational New Drug (IND)-Antrag für Lucid-21-302 (Lucid-MS) vorzubereiten, mit dem Ziel, diesen im vierten Quartal 2025 bei der FDA einzureichen. Die erfolgreiche IND-Zulassung ermöglicht dem Unternehmen die Durchführung von Phase-2-Studien zur Behandlung von Multipler Sklerose.
Lucid-21-302 ist eine erstklassige, nicht-immunmodulatorische, neuroprotektive Verbindung mit einem einzigartigen Wirkmechanismus. Diese patentierte Neue Chemische Substanz hat in präklinischen Modellen die Fähigkeit gezeigt, die Demyelinisierung zu verhindern, eine bekannte Ursache von MS und anderen neurodegenerativen Erkrankungen, die die Myelinscheide um Nervenfasern betreffen.
- Development of a first-in-class treatment for multiple sclerosis with unique mechanism of action
- Preclinical success in preventing demyelination
- Planned FDA submission in Q4 2025 for Phase 2 trial advancement
- Still in early stages with only preclinical data available
- No guarantee of FDA approval for IND application
- Significant time and resources required before potential commercialization
TORONTO, May 20, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces that it has signed an agreement with a global pharmaceutical contract research organization to prepare an IND (Investigational New Drug) application package for Lucid-21-302 (Lucid-MS) with the US FDA. A successful IND application will allow Quantum Biopharma to move forward with a Phase 2 trial of Lucid-21-302 in people with multiple sclerosis (MS).
Lucid-21-302 is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action for the treatment of MS. It is a patented New Chemical Entity (NCE) that has been shown in preclinical models to prevent demyelination, a known cause of MS and other neurogenerative diseases characterized by damage to the myelin sheath surrounding nerve fibers.
“We are pleased to announce that we have signed this agreement to prepare the IND application package, which we hope to submit to the FDA in Q4 2025. This agreement takes us a step closer to initiating the phase 2 trial of Lucid-21-302, a first-in-class treatment for MS,” said Zeeshan Saeed, CEO of Quantum BioPharma.
About Quantum BioPharma Ltd.
Quantum BioPharma (NASDAQ: QNTM) is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), Quantum BioPharma is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum BioPharma invented unbuzzd™ and spun out its OTC version to a company, Celly Nutrition Corp. (“Celly Nutrition”), led by industry veterans. Quantum BioPharma retains ownership of
For more information on Quantum BioPharma, please visit www.quantumbiopharma.com.
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Contacts:
Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: Zsaeed@quantumbiopharma.com
Telephone: (833) 571-1811
Investor Relations
Investor Relations: IR@QuantumBioPharma.com
General Inquiries: info@QuantumBioPharma.com
FAQ
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