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
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- 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.”
In MS, the immune system mistakenly attacks and damages the myelin sheath, the protective coating surrounding nerve fibers that helps them transmit signals efficiently. This destructive process, known as demyelination, disrupts normal nerve signaling and ultimately leads to disease symptoms.
Most available MS treatments work by suppressing immune activity, which can help slow disease progression. However, such therapies may increase the risk of infections and other side effects, and they cannot reverse existing nerve damage.
Lucid-MS targets mechanisms underlying MS disease progression
Lucid-MS, also known as Lucid-21-302, is designed to take a different approach. The investigational therapy targets a group of enzymes called peptidyl arginine deiminases, which are overactive in MS and make myelin more susceptible to immune damage.
By blocking these enzymes, the therapy aims to prevent demyelination and promote myelin repair. This is expected to potentially reverse some of the nerve damage seen in MS patients and restore lost functions.
According to Quantum, preclinical studies have shown that Lucid-MS can improve motor function and reduce symptom severity in MS animal models. In earlier Phase 1 studies involving healthy adult volunteers, the therapy has also been found safe and well tolerated.
The company has been preparing for months to seek FDA permission to begin a Phase 2 trial of Lucid-MS in people with MS. But the regulatory agency had requested two toxicology studies to support the IND application, which have only recently been completed. Now, the FDA submission will come soon, according to Quantum.
Napoli is ready.
“I look forward to working with Quantum BioPharma to evaluate this investigational approach with Lucid-MS,” Napoli said. “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.”
