Daily doses of Lucid-MS found safe in healthy adults in new study
Developer now will seek FDA OK to test therapy candidate in MS patients
Lucid-MS, an oral small-molecule being developed by Quantum Biopharma for treating multiple sclerosis (MS), was found to be safe and well tolerated in healthy adult volunteers when given daily in a clinical study, according to the company’s latest CSR, or clinical study report.
An earlier Phase 1 clinical study (NCT05821387), also involving healthy participants, had shown single doses of Lucid-MS — ranging from 50 to 300 mg — to be well tolerated with no significant safety concerns. According to the newly received CSR, the therapy also maintained its favorable safety profile when administered as consecutive daily doses in this Phase 1 study (NCT06595706).
Quantum is now preparing an application seeking regulatory clearance in the U.S. for a Phase 2 clinical study in MS patients. The company said that it expects to file that submission, now in the works with the help of a global contract research organization, with the U.S. Food and Drug Administration (FDA) by the end of this year.
“Lucid-MS was found to be safe and well tolerated in healthy participants. The CSR allows us to advance the clinical development of Lucid-MS as it is a critical component of the investigational new drug (IND) application with the FDA,” Andrzej Chruscinski, MD, PhD, Quantum’s vice-president of clinical and scientific affairs, said in a company press release.
For Lakshmi P. Kotra, PhD, Quantum’s president and CEO of its Australian subsidiary, the “results and observations from the first-in-human studies, including this … investigation, give us the confidence that Lucid-MS is safe and [well tolerated] in healthy volunteers.”
Kotra, also a professor at the University of Toronto in Canada, led the discovery of Lucid-MS, according to Quantum.
Unlike other therapies, Lucid-MS won’t suppress immune system
In MS, the immune system mistakenly attacks the myelin sheath that insulates nerve fibers in the brain and spinal cord, leading to its hallmark motor and nonmotor symptoms.
Lucid-MS, also known as Lucid-21-302, is designed to protect against this demyelination and to promote remyelination — the repair or restoration of damaged myelin
A small-molecule compound, Lucid-MS blocks a type of enzymes known as peptidyl arginine deiminases. These enzymes are overactive in MS and other neurodegenerative diseases, contributing to the process of demyelination. By blocking these enzymes, Lucid-MS is expected to ease symptoms of MS.
[The] Quantum team is preparing for the launch of efficacy trials in patients with MS. … We are very excited.
Unlike other treatments, this experimental therapy does not suppress the immune system, which can increase the risk of infections. In the release, Quantum called the treatment “a first-in-class … neuroprotective compound with a unique mechanism of action.”
Kotra said the “Quantum team is preparing for the launch of efficacy trials in patients with MS,” adding, “We are very excited.”
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