Quantum BioPharma Signs Agreement to Manufacture Oral Drug Formulation of its Potential Breakthrough Drug Lucid-21-302 (Lucid-MS) for Use in its Upcoming Phase 2 Multiple Sclerosis Trial
Quantum BioPharma (NASDAQ: QNTM) has signed an agreement with a leading CDMO to manufacture an oral formulation of Lucid-MS (Lucid-21-302) for its upcoming Phase 2 clinical trial in multiple sclerosis treatment.
Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound designed to prevent demyelination, a characteristic feature of MS. The drug has shown promising results in animal models over the past decade, demonstrating potential in helping subjects regain walking ability. The oral formulation development represents a crucial step as the company prepares its Investigational New Drug (IND) application with the FDA.
Quantum BioPharma (NASDAQ: QNTM) ha firmato un accordo con una CDMO di primo piano per produrre una formulazione orale di Lucid-MS (Lucid-21-302) in vista del prossimo trial di Fase 2 nel trattamento della sclerosi multipla.
Lucid-MS 猫 un composto first-in-class, non immunomodulatorio e neuroprotettivo progettato per prevenire la demielinizzazione, caratteristica della SM. Il farmaco ha mostrato risultati promettenti in modelli animali nell'ultimo decennio, evidenziando il potenziale per favorire il recupero della deambulazione. Lo sviluppo della formulazione orale rappresenta un passo cruciale mentre la societ脿 prepara la domanda IND (Investigational New Drug) alla FDA.
Quantum BioPharma (NASDAQ: QNTM) ha firmado un acuerdo con un CDMO l铆der para fabricar una formulaci贸n oral de Lucid-MS (Lucid-21-302) para su pr贸ximo ensayo de Fase 2 en el tratamiento de la esclerosis m煤ltiple.
Lucid-MS es un compuesto first-in-class, no inmunomodulador y neuroprotector dise帽ado para prevenir la desmielinizaci贸n, rasgo caracter铆stico de la EM. El medicamento ha mostrado resultados prometedores en modelos animales durante la 煤ltima d茅cada, demostrando potencial para ayudar a los sujetos a recuperar la capacidad de caminar. El desarrollo de la formulaci贸n oral es un paso crucial mientras la compa帽铆a prepara su solicitud IND (Investigational New Drug) ante la FDA.
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Quantum BioPharma (NASDAQ: QNTM) a sign茅 un accord avec un CDMO de premier plan pour fabriquer une formulation orale de Lucid-MS (Lucid-21-302) en vue de son essai clinique de phase 2 脿 venir pour le traitement de la scl茅rose en plaques.
Lucid-MS est un compos茅 first-in-class, non immunomodulateur et neuroprotecteur con莽u pour pr茅venir la d茅my茅linisation, caract茅ristique de la SEP. Le m茅dicament a montr茅 des r茅sultats prometteurs chez l'animal au cours de la derni猫re d茅cennie, d茅montrant un potentiel pour aider les sujets 脿 retrouver la capacit茅 de marcher. Le d茅veloppement de la formulation orale repr茅sente une 茅tape cruciale alors que la soci茅t茅 pr茅pare sa demande IND (Investigational New Drug) aupr猫s de la FDA.
Quantum BioPharma (NASDAQ: QNTM) hat eine Vereinbarung mit einem f眉hrenden CDMO geschlossen, um eine orale Formulierung von Lucid-MS (Lucid-21-302) f眉r die bevorstehende Phase-2-Studie zur Behandlung der Multiplen Sklerose herzustellen.
Lucid-MS ist eine first-in-class, nicht immunmodulierende, neuroprotektive Verbindung, die entwickelt wurde, um die Demyelinisierung 鈥� ein charakteristisches Merkmal der MS 鈥� zu verhindern. Das Pr盲parat zeigte in Tiermodellen im letzten Jahrzehnt vielversprechende Ergebnisse und hat Potenzial, Patienten beim Wiedererlangen der Gehf盲higkeit zu unterst眉tzen. Die Entwicklung der oralen Formulierung ist ein entscheidender Schritt, w盲hrend das Unternehmen seine Investigational New Drug (IND)-Anmeldung bei der FDA vorbereitet.
- Advancement to Phase 2 clinical trials indicates promising development progress
- Successful preclinical results showing mobility improvement in animal models
- Partnership with leading CDMO strengthens manufacturing capabilities
- Novel drug mechanism targeting an unmet medical need in MS treatment
- No human efficacy data available yet
- Success in animal models doesn't guarantee human trial success
- Timeline for FDA approval and commercialization remains uncertain
Insights
Quantum advances MS drug Lucid-MS to Phase 2 with oral formulation, showing promising preclinical results in remyelination.
Quantum BioPharma's announcement represents a significant developmental milestone for Lucid-MS (Lucid-21-302), their potential breakthrough treatment for multiple sclerosis. The company has secured manufacturing capabilities for an oral formulation of the drug, marking a critical step toward their upcoming Phase 2 clinical trial.
What's scientifically noteworthy is that Lucid-MS employs a novel mechanism of action distinct from existing MS therapies. While most approved MS treatments are immunomodulatory (targeting the immune system's attack on myelin), Lucid-MS is described as non-immunomodulatory and neuroprotective, specifically targeting the demyelination process itself. This approach could potentially address a fundamental aspect of MS pathology rather than just managing immune response.
The preclinical results deserve particular attention 鈥� the company reports that animal models demonstrated restoration of walking ability over the past decade of testing. If these results translate to humans, this could represent a paradigm shift in MS treatment from merely slowing progression to actually reversing disability.
The progression to Phase 2 trials, bypassing extensive Phase 1 safety studies (which aren't mentioned in the release), suggests the company may be leveraging existing safety data or regulatory pathways. The fact that they're preparing an IND application with the FDA indicates they're still in the pre-approval process for clinical testing in the US.
As a New Chemical Entity (NCE) with patent protection, Lucid-MS would have market exclusivity if approved, potentially offering Quantum significant commercial advantages if clinical trials prove successful.
TORONTO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) (鈥�Quantum BioPharma鈥� or the 鈥�Company鈥�), a biopharmaceutical company dedicated to innovative therapies for neurodegenerative disorders, today announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has signed an agreement with a leading contract development and manufacturing organization (CDMO) to manufacture an oral drug formulation of Lucid-MS. The oral formulation of Lucid-MS will serve as the drug product for the Company鈥檚 Phase 2 clinical trial, which will test the efficacy on humans of Lucid-MS as a possible treatment for people to gain back mobility lost with multiple sclerosis (MS). To date numerous animal models over the past decade showed Lucid-MS helped those animals regain their ability to walk. Videos can be seen at听.
Lucid-MS 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, which is a hallmark of MS and other neurogenerative diseases and is characterized by damage to the myelin sheath surrounding nerve fibers.
鈥淲e are pleased to announce that we have signed this agreement with a leading CDMO to develop and manufacture an oral formulation of Lucid-MS. This marks an important step in the clinical development of Lucid-MS as we prepare the Investigational New Drug (IND) application with the FDA and prepare for our upcoming Phase 2 trial of Lucid-21-302 in MS,鈥� said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at 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. (鈥�Lucid鈥�), 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鈩� and spun out its OTC version to a company, Unbuzzd Wellness Inc. (formerly Celly Nutrition Corp.), led by industry veterans. Quantum BioPharma retains ownership of
For more information on Quantum BioPharma, please visit .
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Contacts:
Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email:
Telephone: (833) 571-1811
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FAQ
What is the purpose of Quantum BioPharma's Lucid-MS drug?
What stage of development is QNTM's Lucid-MS currently in?
What results has Lucid-MS shown in preclinical studies?
How will Quantum BioPharma manufacture Lucid-MS for its Phase 2 trial?
What makes Lucid-MS different from other MS treatments?
