Quantum Biopharma Announces Positive Results of the Clinical Study Report (CSR) for the Phase 1 Multiple Ascending Dose (MAD) Clinical Trial of Experimental Multiple Sclerosis Drug Lucid-21-302 (Lucid-MS)
Quantum BioPharma (NASDAQ: QNTM) has announced positive results from its Phase 1 Multiple Ascending Dose (MAD) clinical trial for Lucid-MS, their experimental multiple sclerosis drug. The Clinical Study Report (CSR) confirms that Lucid-MS demonstrated safety and tolerability in healthy participants with consecutive daily dosing.
Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound designed to prevent demyelination, a characteristic feature of multiple sclerosis. The successful completion of this trial and CSR marks a crucial milestone, enabling the company to proceed with its Investigational New Drug (IND) application to the FDA and advance toward efficacy trials in MS patients.
Quantum BioPharma (NASDAQ: QNTM) ha annunciato risultati positivi dal suo studio clinico di Fase 1 con dosi multiple ascendenti (MAD) per Lucid-MS, il loro farmaco sperimentale per la sclerosi multipla. Il Rapporto dello Studio Clinico (CSR) conferma che Lucid-MS ha dimostrato sicurezza e tollerabilit脿 nei partecipanti sani con somministrazioni giornaliere consecutive.
Lucid-MS 猫 un composto neuroprotettivo innovativo, non immunomodulatorio, di prima classe progettato per prevenire la demielinizzazione, una caratteristica tipica della sclerosi multipla. Il completamento con successo di questo trial e del CSR rappresenta una tappa fondamentale, permettendo all'azienda di procedere con la domanda di Nuovo Farmaco Sperimentale (IND) alla FDA e avanzare verso studi di efficacia nei pazienti con SM.
Quantum BioPharma (NASDAQ: QNTM) ha anunciado resultados positivos de su ensayo cl铆nico de Fase 1 con dosis m煤ltiples ascendentes (MAD) para Lucid-MS, su medicamento experimental para la esclerosis m煤ltiple. El Informe del Estudio Cl铆nico (CSR) confirma que Lucid-MS demostr贸 seguridad y tolerabilidad en participantes sanos con dosis diarias consecutivas.
Lucid-MS es un compuesto neuroprotector innovador, no inmunomodulador y de primera clase dise帽ado para prevenir la desmielinizaci贸n, una caracter铆stica t铆pica de la esclerosis m煤ltiple. La finalizaci贸n exitosa de este ensayo y del CSR marca un hito crucial, permitiendo a la compa帽铆a avanzar con su solicitud de Nuevo F谩rmaco en Investigaci贸n (IND) ante la FDA y progresar hacia ensayos de eficacia en pacientes con EM.
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Lucid-MS電� 雼る皽靹� 瓴巾檾歃濎潣 韸轨鞚� 韮堨垬齑堧ゼ 鞓堧癌頃橁赴 鞙勴暣 靹り硠霅� 斓滌磮鞚� 牍勲┐鞐“鞝� 鞁犼步氤错樃 頇旐暕氍�鞛呺媹雼�. 鞚措矆 鞁滍棙瓿� CSR鞚� 靹标车鞝侅澑 鞕勲電� 須岇偓臧� FDA鞐� 鞁犾暯 鞛勳儊鞁滍棙 鞀轨澑(IND) 鞁犾箔鞚� 歆勴枆頃橁碃 雼る皽靹� 瓴巾檾歃� 頇橃瀽毳� 雽�靸侅溂搿� 須姤 鞁滍棙鞙茧 雮橃晞臧� 靾� 鞛堧姅 欷戩殧頃� 鞚挫爼響滌瀰雼堧嫟.
Quantum BioPharma (NASDAQ : QNTM) a annonc茅 des r茅sultats positifs issus de son essai clinique de phase 1 脿 doses multiples ascendantes (MAD) pour Lucid-MS, son m茅dicament exp茅rimental contre la scl茅rose en plaques. Le rapport d'茅tude clinique (CSR) confirme que Lucid-MS a d茅montr茅 sa s茅curit茅 et sa tol茅rabilit茅 chez des participants sains lors d'une administration quotidienne cons茅cutive.
Lucid-MS est un compos茅 neuroprotecteur innovant, non immunomodulateur, de premi猫re classe con莽u pour pr茅venir la d茅my茅linisation, une caract茅ristique typique de la scl茅rose en plaques. La r茅ussite de cet essai et du CSR constitue une 茅tape cruciale, permettant 脿 l'entreprise de d茅poser sa demande de m茅dicament exp茅rimental (IND) aupr猫s de la FDA et de progresser vers des essais d'efficacit茅 chez les patients atteints de SEP.
Quantum BioPharma (NASDAQ: QNTM) hat positive Ergebnisse aus seiner Phase-1-Studie mit mehrfach ansteigenden Dosen (MAD) f眉r Lucid-MS, ihr experimentelles Medikament gegen Multiple Sklerose, bekannt gegeben. Der Clinical Study Report (CSR) best盲tigt, dass Lucid-MS bei gesunden Teilnehmern mit aufeinanderfolgenden t盲glichen Dosierungen Sicherheit und Vertr盲glichkeit zeigte.
Lucid-MS ist eine erstklassige, nicht-immunmodulatorische, neuroprotektive Verbindung, die entwickelt wurde, um die Demyelinisierung zu verhindern, ein charakteristisches Merkmal der Multiplen Sklerose. Der erfolgreiche Abschluss dieser Studie und des CSR stellt einen entscheidenden Meilenstein dar, der es dem Unternehmen erm枚glicht, den Antrag auf ein Investigational New Drug (IND) bei der FDA einzureichen und mit Wirksamkeitsstudien bei MS-Patienten fortzufahren.
- Successful completion of Phase 1 MAD trial with positive safety and tolerability results
- Novel non-immunomodulatory mechanism of action, differentiating from existing MS treatments
- CSR completion enables advancement to FDA IND application
- Patented New Chemical Entity (NCE) status provides intellectual property protection
- Early-stage development - efficacy in MS patients yet to be demonstrated
- Additional clinical trials required before potential commercialization
- No efficacy data available yet as study was conducted in healthy volunteers
Insights
Quantum's MS drug Lucid-MS passed Phase 1 safety trial, clearing path for efficacy studies with novel non-immunomodulatory mechanism.
Quantum BioPharma has achieved a significant milestone with their experimental multiple sclerosis drug Lucid-21-302 (Lucid-MS). The Clinical Study Report (CSR) from their Phase 1 Multiple Ascending Dose trial demonstrated no safety or tolerability concerns in healthy participants following consecutive daily dosing. This successful completion of early-stage safety testing represents a critical step in the drug development pathway.
What distinguishes Lucid-MS in the competitive MS treatment landscape is its novel mechanism of action. Unlike existing MS therapies that primarily target the immune system, Lucid-MS is described as a non-immunomodulatory, neuroprotective compound. The drug specifically aims to prevent demyelination 鈥� the degradation of the protective myelin sheath around nerve fibers that characterizes MS. This represents a fundamentally different approach to treating the disease.
The Phase 1 MAD results are particularly meaningful as they form a crucial component of the company's upcoming investigational new drug (IND) application with the FDA. With this safety data secured, Quantum is now preparing to advance to efficacy trials in actual MS patients. For a first-in-class compound with a novel mechanism, clearing the initial safety hurdle without concerns provides validation for the continued development program.
As a patented New Chemical Entity (NCE) with promising preclinical data and now human safety confirmation, Lucid-MS represents a potentially valuable asset in Quantum's neuropharmaceutical portfolio. The drug's progression from discovery through preclinical testing and now successful Phase 1 studies demonstrates the company's ability to advance novel compounds through the critical early stages of development.
TORONTO, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (鈥�Quantum BioPharma鈥� or the 鈥�Company鈥�), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has received the clinical study report (CSR) for the trial entitled 鈥淎 Phase 1, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-MS in Healthy Adult Participants.鈥� The CSR concludes that there were no safety or tolerability concerns that were identified in healthy participants following treatment with consecutive daily dosing of Lucid-MS.
Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action for the treatment of multiple sclerosis (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 thrilled that we now have the CSR for the Phase 1 MAD trial and that Lucid-MS was found to be safe and well-tolerated in healthy participants. The CSR allows us to advance the clinical development of Lucid-MS as it is a critical component of the investigational new drug (IND) application with the FDA,鈥� said Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs at Quantum BioPharma.
鈥淩esults and observations from the first-in-human studies including this MAD investigation give us the confidence that Lucid-MS is safe and tolerable in healthy volunteers,鈥� said Dr. Lakshmi P. Kotra, Director at Quantum BioPharma and a Professor at University of Toronto, who led the discovery of Lucid-MS. 鈥淨uantum team is preparing for the launch of efficacy trials in patients with MS which is very exciting. This compound follows a novel non-immunomodulatory mechanism, and we are very excited to be planning human efficacy trials.鈥�
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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FAQ
What were the results of Quantum BioPharma's (QNTM) Phase 1 MAD trial for Lucid-MS?
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