Mr. Zeeshan Saeed reports
QUANTUM BIOPHARMA ANNOUNCES APPOINTMENT OF PRINCIPAL INVESTIGATOR FOR PLANNED PHASE 2 CLINICAL TRIAL OF LUCID-21-302 (LUCID-MS) IN MULTIPLE SCLEROSIS
Quantum Biopharma Ltd. has appointed Dr. Salvatore Napoli, MD, as principal investigator for its planned phase 2 clinical trial evaluating Lucid-21-302 (Lucid-MS), an investigational therapy being developed to target demyelination in multiple sclerosis.
Dr. Napoli is an internationally recognized neurologist and key opinion leader in MS, with over 20 years of clinical and research experience. He is president and medical director of the Neurology Center of New England and the MS Center of New England, where he leads advanced clinical and research programs in MS. Dr. Napoli completed specialized fellowship training in MS and neuroimmunology at the Brigham and Women's Hospital, and has held academic appointments at Harvard medical school. He has served as a principal investigator and subinvestigator on numerous clinical trials in MS, and his work has focused on advancing innovative approaches to treating neurodegenerative disorders.
Quantum Biopharma intends to submit an investigational new drug application for Lucid-MS to the U.S. Food and Drug Administration in the coming weeks. The IND application includes the design of the phase 2 trial of Lucid-MS. Subject to regulatory clearance of the IND, the planned clinical trial will evaluate the efficacy, safety and tolerability of Lucid-MS in people with MS.
"We are pleased to collaborate with Dr. Napoli as we advance our clinical development program," said Andrzej Chruscinski, vice-president, scientific and clinical affairs, at Quantum Biopharma. "Disease progression and demyelination remain areas of significant unmet medical need in MS, and Dr. Napoli's expertise will be invaluable as we prepare for clinical evaluation of Lucid-MS."
Zeeshan Saeed, chief executive officer of Quantum Biopharma, added: "The appointment of Dr. Napoli represents a key milestone as we advance Lucid-MS toward clinical evaluation. As we prepare for a planned phase 2 study, our focus is on targeting biological processes associated with disease progression in MS. We believe this program underscores the potential of our approach to addressing areas of high unmet need in neurodegenerative disease."
"I look forward to working with Quantum Biopharma to evaluate this investigational approach with Lucid-MS," said Dr. Napoli. "Continued research into therapies targeting mechanisms of MS disease progression -- including demyelination and the potential for remyelination -- is critically important for patients and remains an unmet need."
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 that has been shown in preclinical models to prevent demyelination, a hallmark of MS and other neurodegenerative diseases, which is characterized by damage to the myelin sheath surrounding nerve fibres.
About Quantum Biopharma Ltd.
Quantum Biopharma 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., 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 over-the-counter version to a company, Unbuzzd Wellness Inc., led by industry veterans. Quantum Biopharma retains ownership of 19.86 per cent (as of Sept. 30, 2025) of UWI. The agreement with UWI also includes royalty payments of 7 per cent of sales from Unbuzzd until payments to Quantum Biopharma total $250-million. Once $250-million is reached, the royalty drops to 3 per cent in perpetuity. Additionally, Quantum Biopharma retains a large tax loss carry forward of approximately $130-million and could be utilized in the future to offset tax payable obligations against future profits. Quantum Biopharma retains 100 per cent of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses. Quantum Biopharma maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property.
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