Lucid-MS moves toward clinical trial in US that will enroll MS patients

Quantum names principal investigator, to soon seek FDA OK to launch study

Written by Michela Luciano, PhD | March 30, 2026

• Quantum Biopharma soon will be seeking FDA clearance to lauch a clinical trial testing its oral therapy Lucid-MS in people with multiple sclerosis. 
• Lucid-MS is a first-in-class therapy designed to target myelin loss and promote its repair.
• The developer has named an internationally known neurologist from Massachusetts as the trial’s principal investigator.

Quantum Biopharma is preparing to seek permission in the U.S. to launch its planned clinical trial of Lucid-MS, an oral therapy that aims to slow myelin loss — which ultimately results in the neurological problems that drive multiple sclerosis (MS) — in people with the progressive disease.

The company said it expects to submit an investigational new drug (IND) application, which includes the full design of the planned Phase 2 trial, to the U.S. Food and Drug Administration (FDA) in the coming weeks.

If cleared by the regulatory agency, the trial will test the therapy’s safety, tolerability, and potential effectiveness in people living with the disease. As part of preparations for the study, Quantum also announced the appointment of Salvatore Napoli, MD, an internationally known neurologist, as the trial’s principal investigator, according to a company press release.

“The appointment of Dr. Napoli represents a key milestone as we advance Lucid-MS toward clinical evaluation,” said Zeeshan Saeed, CEO of Quantum. “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.”

Napoli, who Quantum calls “a key opinion leader in MS,” is the president and medical director of the Neurology Center of New England and the MS Center of New England, where he oversees clinical and research programs focused on advancing innovative treatments for MS and other neurodegenerative diseases. He completed fellowship training in MS and neuroimmunology at Brigham and Women’s Hospital in Massachusetts and has held academic appointments at Harvard Medical School.

“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,” said Andrzej Chruscinski, MD, PhD, vice president of clinical and scientific affairs at Quantum. “We are pleased to collaborate with Dr. Napoli as we advance our clinical development program.”

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