Quantum BioPharma Receives Final Reports for Two Key Studies of its Potential Breakthrough Drug for Multiple Sclerosis, Moving Closer to Phase 2 Clinical Trial
Quantum BioPharma (NASDAQ: QNTM) has reached a significant milestone in the development of Lucid-21-302 (Lucid-MS), its potential breakthrough drug for Multiple Sclerosis. The company received final reports for two critical studies: the 90-day oral toxicity study and the toxicokinetic study.
These reports will support Quantum's Investigational New Drug (IND) application to the US FDA for a planned Phase 2 clinical trial. Lucid-MS is being developed as a first-in-class treatment targeting demyelination in Multiple Sclerosis patients.
Quantum BioPharma (NASDAQ: QNTM) ha raggiunto una tappa significativa nello sviluppo di Lucid-21-302 (Lucid-MS), il suo potenziale farmaco rivoluzionario per la sclerosi multipla. L'azienda ha ricevuto i report finali di due studi critici: lo studio di tossicità orale a 90 giorni e lo studio tossicocinetico.
Questi rapporti supporteranno la richiesta di Investigational New Drug (IND) da parte di Quantum alla FDA statunitense per un previsto studio clinico di fase 2. Lucid-MS è sviluppato come trattamento di prima classe mirato alla demielinizzazione nei pazienti con sclerosi multipla.
Quantum BioPharma (NASDAQ: QNTM) ha alcanzado un hito significativo en el desarrollo de Lucid-21-302 (Lucid-MS), su posible fármaco innovador para la esclerosis múltiple. La empresa recibió los informes finales de dos estudios críticos: el estudio de toxicidad oral a 90 días y el estudio toxicológico cinético.
Estos informes respaldarán la solicitud de New Drug Investigational (IND) ante la FDA de EE. UU. para un previsto ensayo clínico de fase 2. Lucid-MS se está desarrollando como un tratamiento de primera clase dirigido a la desmielinización en pacientes con esclerosis múltiple.
Quantum BioPharma (NASDAQ: QNTM)가 다발성 경화증용 잠재적 혁신 약물인 Lucid-21-302(Lucid-MS) 개발에서 중요한 이정표를 달성했습니다. 회사는 두 가지 중요한 연구의 최종 보고서를 받았습니다: 90일 구강 독성 연구와 독성동태 연구.
이 보고서는 미국 FDA에 대한 임상시험용 신약(IND) 신청을 뒷받침하여 예정된 2상 임상시험을 위한 것입니다. Lucid-MS는 다발성 경화증 환자의 탈수초화를 표적으로 하는 일차 신약(first-in-class) 치료제로 개발 중입니다.
Quantum BioPharma (NASDAQ: QNTM) a franchi une étape importante dans le développement de Lucid-21-302 (Lucid-MS), son candidat médicament potentiellement révolutionnaire pour la sclérose en plaques. L'entreprise a reçu les rapports finaux de deux études critiques : l'étude de toxicité orale sur 90 jours et l'étude toxicocinétique.
Ces rapports soutiendront la demande de Investigational New Drug (IND) auprès de la FDA américaine pour un essai clinique de phase 2 prévu. Lucid-MS est développé comme premier traitement de sa catégorie visant la démyélinisation chez les patients atteints de sclérose en plaques.
Quantum BioPharma (NASDAQ: QNTM) hat einen bedeutenden Meilenstein bei der Entwicklung von Lucid-21-302 (Lucid-MS) erreicht, seinem potenziellen Durchbruchsmittel gegen Multipler Sklerose. Das Unternehmen hat die Abschlussberichte von zwei entscheidenden Studien erhalten: die 90-tägige orale Toxizitätsstudie und die Toxikokinetik-Studie.
Diese Berichte werden Quantum bei der Investigational New Drug (IND) Anwendung bei der US-FDA für eine geplante Studie der Phase 2 unterstützen. Lucid-MS wird als erstes in seiner Klasse stehendes Behandlung entwickelt, das auf die Demyelinisierung bei MS-Patienten abzielt.
Quantum BioPharma (NASDAQ: QNTM) وصلت إلى علامة فارقة في تطوير Lucid-21-302 (Lucid-MS)، دوائها المحتمل الثوري لمرض التصلب المتعدد. تلقّت الشركة التقارير النهائية لدراستين حيويتين: دراسة السمية الفموية لمدة 90 يومًا ودراسة التحرك الدوائي-سمّي.
هذه التقارير ستدعم طلب Quantum لـ دواء جديد قيد التحقيق (IND) لدى FDA الأمريكية لاختبار سريري في المرحلة الثانية المخطط لها. يتم تطوير Lucid-MS كـ علاج من فئة أولى في فئته يستهدف إزالة الغشاء mielin في مرضى التصلب المتعدد.
Quantum BioPharma (NASDAQ: QNTM) 在开发 Lucid-21-302(Lucid-MS) 方面取得了重要进展，这是其可能对多发性硬化症的突破性药物。公司已收到两项关键研究的最终报告：90天口服毒性研究和药物动力学毒性研究。
这些报告将支持 Quantum 向美国 FDA 提出的调查性新药（IND）申请，以进行计划中的II期临床试验。Lucid-MS 正在开发为一个针对多发性硬化症患者髓鞘脱失的同类首创治疗。
- Receipt of final toxicity study reports marks progress toward IND application
- Potential first-in-class treatment targeting MS demyelination
- Advancing to Phase 2 clinical trial preparation phase
- Drug is still in early development stages with no efficacy data yet
- FDA approval for Phase 2 trials not yet secured
- Multiple regulatory hurdles remain before commercialization
TORONTO, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) (“Quantum BioPharma” or the “Company”), 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, is pleased to announce today that it has received two key final reports related to its potential breakthrough drug for Multiple Sclerosis: the 90-day oral toxicity study report and the toxicokinetic study report for Lucid-21-302 (“Lucid-MS”). These studies were commissioned to provide key data to support an Investigational New Drug (IND) application with the US FDA for a phase-2 clinical trial in Multiple Sclerosis.
“We are pleased that we now have the final reports for these toxicity studies, as this represents an important milestone,” said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma. “These reports will be used to support Quantum’s IND application to the US FDA, further advancing the Lucid-MS drug development program.”
Anthony Durkacz, Executive Co-Chairman of Quantum BioPharma added, “We are very excited about the potential of Lucid-MS as a first-in-class treatment for MS targeting demyelination. With these final reports, we move significantly closer to initiating our Phase 2 trial of Lucid-MS in people with Multiple Sclerosis.”
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”), now Unbuzzd Wellness Inc., led by industry veterans. Quantum BioPharma retains ownership of
For more information visit www.quantumbiopharma.com.
Forward-Looking Information
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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
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