FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE) completed dosing the first cohort of patients in the company’s Phase I clinical trial of Lucid-21-302 (Lucid-MS).
The clinical trial (ClinicalTrials.gov identifier: NCT05821387), which is being conducted by FSD Pharma through the company’s wholly owned subsidiary Lucid Psycheceuticals, is a first-in-human study evaluating Lucid-MS, a small molecule inhibitor of hyper citrullination, as a novel drug candidate for the treatment of multiple sclerosis. Today, there is no cure for MS.
“Our clinical development team and international advisory committee are delighted at the progress of this milestone and completing dosing the first cohort,” said Dr. Lakshmi Kotra, CEO of Lucid Psycheceuticals. “The safety review committee has recommended to move forward with the next cohort dosing, which we are thrilled to say is expected to commence in the next few days.”
MS is known for its unpredictable symptoms, such as tingling sensations, vision problems, and mobility issues, that are attributed to the patient’s immune system attacking different nerve fibers. The global MS treatment market in 2022 is estimated at $23 billion.
MS can occur at any age, but the average age for diagnosis globally is 32 years. Just 1.5% of the global MS population is under the age of 18 years, and the female-to-male diagnosis ratio is 2:1.
The Lucis-MS clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study with the primary outcomes evaluating the safety, tolerability, and pharmacokinetics in healthy volunteers under fed and fasted conditions.
Enrollment will be comprised of five SAD cohorts and two MAD cohorts. Each SAD and MAD cohort will enroll eight participants (for a total of 56 participants), randomized to six active and two placebo groups. Participants in the active group will receive single or multiple doses of Lucid-MS. For the SAD cohort with food effect, all eight participants will receive Lucid-MS.
In preclinical models, Lucid-MS has been shown to prevent myelin degradation (demyelination), a hallmark pathology feature of MS and other neurogenerative diseases characterized by damage to the myelin sheath surrounding nerve fibers in the central nervous system.
Preclinical evidence demonstrated Lucid-MS promotes functional recovery in experimental animal models of MS. Based on current evidence, Lucid-MS is a nonimmunomodulatory agent, an important distinction in the potential for developing new, safe options for treating MS.
The company expects to launch the Phase 2 trial in 2024. FSD also has a psilocybin-based compound drug that it is developing for major depressive disorder.