Dosing begins in early clinical trial of Lucid-MS to protect myelin sheath
Safety being tested in healthy adults in preparation for study in patients
A first group of healthy adults has been dosed in a Phase 1 safety and tolerability trial of Lucid-21-302, a potential myelin-protective oral treatment for multiple sclerosis (MS), regardless of disease type.
These initial volunteers will serve as the trial’s sentinels, an occasional study feature allowing for a drug to be given to a few participants, who then are monitored for side effects before the medication is given to other participants. The goal is to limit unanticipated and serious side effects, and to allow for adjustments in a trial’s procedures, or protocol, before more people are dosed.
“We are thrilled that sentinel participants have received their first doses of Lucid-21-302. This marks an important step in advancing the Lucid-21-302 clinical development program in multiple sclerosis,” Andrzej Chruscinski, MD, PhD, vice president of scientific and clinical affairs at Quantum Biopharma, Lucid-MS’s developer, said in a company press release.
Immune system attacks on the myelin sheath of nerve fibers mark MS
The Phase 1 trial (NCT06595706), which is enrolling at a single site in Australia, is expected to include about 16 healthy adults, ages 18 to 60. They will receive ascending doses of Lucid-MS or a placebo for multiple days, with the goal of better understanding the safety and pharmacological profile of the experimental treatment.
Trial findings, expected early next year, are expected to inform the design of a Phase 2 clinical trial into the safety and efficacy of Lucid-MS in people with MS.
“This brings us one step closer to … phase-2 efficacy trials with Lucid-21-302,” said Lakshmi Kotra, PhD, a professor of medical chemistry at the University of Toronto who discovered Lucid-MS and serves on Quantum’s board. “We strongly believe [Lucid-MS] will prove to be a potentially promising therapeutic when it advances into phase-2 efficacy clinical trials for the treatment of degenerative condition in multiple sclerosis.”
MS is caused by the immune system mistakenly attacking the myelin sheath, a protective coating around nerve fibers that’s essential for rapid nerve cell communication.
While more than 20 MS disease-modifying therapies are approved for MS, particularly for relapsing forms primarily due to active inflammation, they mainly work by reducing immune system responses. This can impact the body’s ability to fight infections and other diseases, and none of these treatments can properly repair existing myelin damage and restore lost function.
Lucid-MS aims to protect myelin against damage and enable repair
Lucid-MS is a compound designed to prevent, and possibly repair, ongoing damage to the myelin sheath without affecting the immune system. In animal models of MS, treatment with Lucid-MS after evident tail and hind limb paralysis was reported to restore mobility. After 1.5 months of treatment, “the mice mostly recovered with mild symptoms,” the company details in a website video. “Functional recovery was observed” a few days later, the video’s speaker reports.
The ongoing trial is being led by Quantum’s subsidiary, Huge Biopharma Australia. It follows an earlier Phase 1 trial (NCT05821387) in which 40 healthy volunteers received Lucid-MS at ascending doses or a placebo, but with each person randomized to treatment given a single dose.
Lucid-MS was found in this study to be safe and well tolerated at doses ranging from 50 to 300 mg, with no serious side effects evident. Most adverse events were reported to be minor and considered unlikely to be related to the therapy.
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