A Phase 1 clinical trial has commenced to evaluate the safety and tolerability of Lucid-21-302 (Lucid-MS), an investigational oral treatment aimed at protecting the myelin sheath in individuals with multiple sclerosis (MS). The trial, identified as NCT06595706, is enrolling healthy adult volunteers in Australia to assess the drug's pharmacological profile and inform future efficacy studies.
Trial Design and Objectives
The Phase 1 trial is a single-site study involving approximately 16 healthy adults aged 18 to 60. Participants will receive ascending doses of Lucid-MS or a placebo over several days. The primary objective is to evaluate the safety and tolerability of the experimental treatment, with results expected in early next year. These findings will be crucial in designing a Phase 2 clinical trial to assess the safety and efficacy of Lucid-MS in patients with MS.
Mechanism of Action and Preclinical Data
Lucid-MS is a compound designed to prevent and potentially repair ongoing damage to the myelin sheath, the protective coating around nerve fibers that is essential for rapid nerve cell communication. Unlike many existing MS therapies that suppress the immune system, Lucid-MS aims to protect myelin without affecting immune function. Preclinical studies in animal models of MS have shown promising results, with Lucid-MS treatment leading to restored mobility after paralysis. According to Quantum Biopharma, after 1.5 months of treatment, mice mostly recovered with mild symptoms, and functional recovery was observed a few days later.
Current MS Treatment Landscape and Unmet Needs
Multiple sclerosis is characterized by the immune system mistakenly attacking the myelin sheath, leading to impaired nerve cell communication and various neurological symptoms. While over 20 disease-modifying therapies are approved for MS, particularly for relapsing forms, these treatments primarily focus on reducing immune system responses. These therapies can impact the body's ability to fight infections and other diseases, and none of them can effectively repair existing myelin damage and restore lost function. Lucid-MS represents a novel approach by directly targeting myelin protection and repair, potentially addressing a significant unmet need in MS treatment.
Previous Clinical Experience
This Phase 1 trial follows an earlier Phase 1 trial (NCT05821387) in which 40 healthy volunteers received single ascending doses of Lucid-MS or a placebo. The previous study found Lucid-MS to be safe and well-tolerated at doses ranging from 50 to 300 mg, with no serious side effects reported. Most adverse events were minor and considered unlikely to be related to the therapy. "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," said Andrzej Chruscinski, MD, PhD, vice president of scientific and clinical affairs at Quantum Biopharma.
