Quantum Biopharma Announces Completion of the Phase 1 Multiple Ascending Dose Clinical Trial for its Experimental Multiple Sclerosis Drug Lucid-21-302
Quantum BioPharma (NASDAQ: QNTM) has successfully completed its Phase 1 Multiple Ascending Dose clinical trial for Lucid-21-302 (Lucid-MS), a novel multiple sclerosis drug. The Safety Review Committee confirmed the drug was well-tolerated with no safety concerns or serious adverse events reported.
Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound featuring a unique mechanism of action. Preclinical models demonstrated its ability to stabilize the myelin sheath surrounding nerve fibers, potentially protecting against demyelination - a key characteristic of MS that leads to progressive disability.
Following this milestone, the company is preparing to advance to Phase 2 trials in MS patients, moving closer to their goals of drug approval and commercialization.
Quantum BioPharma (NASDAQ: QNTM) ha completato con successo il suo studio clinico di Fase 1 su dosi multiple ascendenti per Lucid-21-302 (Lucid-MS), un nuovo farmaco per la sclerosi multipla. Il Comitato di Revisione della Sicurezza ha confermato che il farmaco è stato ben tollerato, senza preoccupazioni per la sicurezza o eventi avversi gravi riportati.
Lucid-MS è un composto di prima classe, non immunomodulatore, neuroprotettivo, con un meccanismo d'azione unico. I modelli preclinici hanno dimostrato la sua capacità di stabilizzare la guaina mielinica che circonda le fibre nervose, potenzialmente proteggendo contro la demielinizzazione, una caratteristica chiave della SM che porta a disabilità progressive.
Dopo questo traguardo, l'azienda si sta preparando a passare alla fase 2 degli studi clinici su pazienti affetti da SM, avvicinandosi ai suoi obiettivi di approvazione del farmaco e commercializzazione.
Quantum BioPharma (NASDAQ: QNTM) ha completado con éxito su ensayo clínico de Fase 1 de dosis múltiples ascendentes para Lucid-21-302 (Lucid-MS), un nuevo fármaco para la esclerosis múltiple. El Comité de Revisión de Seguridad confirmó que el fármaco fue bien tolerado, sin preocupaciones de seguridad ni eventos adversos graves reportados.
Lucid-MS es un compuesto de primera clase, no inmunomodulador y neuroprotector, que presenta un mecanismo de acción único. Los modelos preclínicos demostraron su capacidad para estabilizar la vaina de mielina que rodea las fibras nerviosas, protegiendo potencialmente contra la desmielinización, una característica clave de la EM que conduce a discapacidades progresivas.
Tras este hito, la empresa se está preparando para avanzar a ensayos de Fase 2 en pacientes con EM, acercándose a sus objetivos de aprobación y comercialización del fármaco.
퀀텀 바이오파마 (NASDAQ: QNTM)는 루시드-21-302 (루시드-MS)에 대한 1상 다중 상승 용량 임상 시험을 성공적으로 완료했습니다. 안전성 검토 위원회는 이 약물이 안전성 문제나 심각한 부작용 없이 잘 견디는 것으로 확인했습니다.
루시드-MS는 독특한 작용 메커니즘을 가진 1급 비면역조절 신경 보호 화합물입니다. 전임상 모델은 신경 섬유를 둘러싼 미엘린 수초를 안정화시키는 능력을 보여주었으며, 이는 탈수초화로부터 보호할 수 있는 가능성이 있습니다. 탈수초화는 진행성 장애로 이어지는 다발성 경화증의 주요 특성입니다.
이 이정표를 지나, 회사는 다발성 경화증 환자를 대상으로 2상 시험으로 나아갈 준비를 하고 있으며, 약물 승인 및 상용화 목표에 더 가까워지고 있습니다.
Quantum BioPharma (NASDAQ: QNTM) a réussi à compléter son essai clinique de Phase 1 sur des doses multiples ascendantes pour Lucid-21-302 (Lucid-MS), un nouveau médicament contre la sclérose en plaques. Le Comité de Révision de la Sécurité a confirmé que le médicament était bien toléré, sans préoccupations de sécurité ni événements indésirables graves signalés.
Lucid-MS est un composé de première classe, non immunomodulateur et neuroprotecteur, présentant un mécanisme d'action unique. Des modèles précliniques ont démontré sa capacité à stabiliser la gaine de myéline entourant les fibres nerveuses, protégeant potentiellement contre la démyélinisation, une caractéristique clé de la SEP qui conduit à une incapacité progressive.
Après cette étape, l'entreprise se prépare à passer aux essais de Phase 2 chez des patients atteints de SEP, se rapprochant ainsi de ses objectifs d'approbation et de commercialisation du médicament.
Quantum BioPharma (NASDAQ: QNTM) hat erfolgreich seine Phase-1-Studie mit mehrfach steigenden Dosen für Lucid-21-302 (Lucid-MS) abgeschlossen, ein neuartiges Medikament gegen Multiple Sklerose. Der Sicherheitsprüfausschuss bestätigte, dass das Medikament gut vertragen wurde, ohne Sicherheitsbedenken oder schwerwiegende unerwünschte Ereignisse.
Lucid-MS ist eine neuartige, nicht immunmodulatorische, neuroprotektive Verbindung mit einem einzigartigen Wirkmechanismus. Präklinische Modelle zeigten seine Fähigkeit, die Myelinschicht um die Nervenfasern zu stabilisieren und möglicherweise vor Demyelinisierung zu schützen - einem Hauptmerkmal der MS, das zu fortschreitenden Behinderungen führt.
Nach diesem Meilenstein bereitet sich das Unternehmen darauf vor, in die Phase-2-Studien bei MS-Patienten überzugehen und sich somit seinen Zielen der Arzneimittelzulassung und Kommerzialisierung zu nähern.
- Successful completion of Phase 1 trial with no safety concerns
- Novel drug mechanism protecting myelin sheath
- Ready to advance to Phase 2 trials
- Patented New Chemical Entity with unique approach
- Early-stage drug development with no efficacy data yet
- Long path ahead before potential commercialization
Insights
Quantum BioPharma's announcement represents a critical derisking milestone for its lead MS candidate. The successful completion of this Phase 1 multiple ascending dose (MAD) trial demonstrates that Lucid-21-302 can be safely administered repeatedly at increasing doses - essential for a chronic disease like MS requiring long-term treatment.
What makes this program particularly noteworthy is Lucid-MS's novel non-immunomodulatory mechanism. Unlike the
The stark disconnect between Quantum's modest
Looking forward, Quantum faces significant challenges: financing a Phase 2 program likely requiring
This milestone enables Quantum to approach potential partners from a stronger position, but investors should recognize that clinical success in MS typically requires substantial resources and expertise that often exceed small biotech capabilities.
Quantum's Phase 1 MAD trial completion represents a modest but meaningful derisking event in the development of Lucid-MS. For a
The successful safety profile enables Quantum to advance to Phase 2, where the real value-creation opportunity exists. However, this progress highlights a stark valuation disconnect: comparable MS-focused biotechs typically trade at
A Phase 2 proof-of-concept study in MS patients will require an estimated
- Capital raise at current depressed valuations (highly dilutive)
- Partnership with a larger pharma company (most favorable outcome)
- Development delays while seeking alternative funding
The investment thesis hinges on Lucid-MS's novel neuroprotective mechanism potentially addressing unmet needs across all MS subtypes. If successful, particularly in progressive MS where few effective treatments exist, peak sales potential could exceed
Quantum's management will need to leverage this Phase 1 success to secure either partnership interest or investor capital before cash constraints force unfavorable decisions. With Phase 2 results representing the true value inflection point (likely 18-24 months away if initiated promptly), current valuation provides asymmetric risk-reward for investors comfortable with binary biotech risk profiles and potential financing hurdles.
Safety Review Committee Found No Safety Concerns Following Milestone Trial
TORONTO, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), today announced that it has completed its trial entitled “A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants.” A final safety review committee (“SRC”) meeting was held after completion of the trial. The SRC found that Lucid-21-302 “(Lucid-MS”) was well-tolerated with no safety concerns and no serious adverse events were reported during the trial.
Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound for the treatment of multiple sclerosis (“MS”). It is a patented New Chemical Entity (“NCE”) that has a unique mechanism of action. As shown in preclinical models of MS, it can directly stabilize the myelin sheath surrounding nerve fibers and thus provide protection from demyelination. MS is a disease characterized by demyelination, a process that causes progressive disability.
“Our clinical development team is thrilled that this Phase 1 trial is now complete, and that Lucid-MS was deemed safe and well-tolerated in healthy participants,” said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma. “This marks an important milestone and allows for the next steps in the clinical development of Lucid-MS.”
Zeeshan Saeed, CEO of Quantum BioPharma added, “We are excited about potential of Lucid-MS to protect myelin in MS patients as it represents a new direction in the treatment of this disease. By completing this trial and demonstrating safety in healthy participants, we are now closer to initiating a Phase 2 trial of Lucid-MS in people with MS.
“We are now looking ahead to our Phase 2 trial as we work towards our goals of drug approval and commercialization of Lucid-MS. We look forward to providing further updates as we execute on our milestones, driven by our mission to arrest demyelination in MS,” concluded Saeed.
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
Forward Looking Information
This press release contains certain “forward-looking statements” within the meaning of applicable Canadian securities law. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, identified by words or phrases such as “believes”, “anticipates”, “expects”, “is expected”, “scheduled”, “estimates”, “pending”, “intends”, “plans”, “forecasts”, “targets”, or “hopes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “will”, “should” “might”, “will be taken”, or “occur” and similar expressions) are not statements of historical fact and may be forward-looking statements. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the Company’s focus on the research and development of Lucid-MS to prevent and reverse myelin degradation; the Company’s Lucid-21-302 clinical development program in multiple sclerosis advancing towards human phase-2 efficacy trials; the Company’s intention to retain
Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s assessment of market conditions, its ability to gain market share, and its potential competitive edge are accurate; the Company will have the ability to carry out its plans with respect to its new innovation and offerings, including its ability to conduct research and development of Lucid-MS; the Company’s Lucid-21-302 clinical development program in multiple sclerosis will advance towards human phase-2 efficacy trials; the Company will retain
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the Company’s inability to retain
The reader is urged to refer to additional information relating to Quantum BioPharma, including its annual information form, can be located on the SEDAR+ website at www.sedarplus.ca and on the EDGAR section of the United States Securities and Exchange Commission’s website at www.sec.gov for a more complete discussion of such risk factors and their potential effects.
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
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
QNTM@mzgroup.us
www.mzgroup.us
FAQ
What were the results of Quantum BioPharma's (QNTM) Phase 1 trial for Lucid-MS?
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