Promising Multiple Sclerosis Drug Candidate Advances: First Clinical Trial Dosing Completed

FSD Pharma Inc. HUGE, a biopharma company developing innovative assets and biotech solutions for the treatment of neurodegenerative, inflammatory and metabolic disorders, announced the first cohort of participants on its Phase 1 study assessing Lucid-21-302, or Lucid-MS, has completed dosing.

Conducted by the company’s wholly-owned subsidiary Lucid Psycheceuticals, the randomized, double-blind, placebo-controlled and both single- and multiple-ascending dose trial aims to assess Lucid-MS, a small molecule inhibitor of hypercitrullination, as a novel therapeutic for cases of Multiple Sclerosis (MS).

This first-in-human study will then evaluate safety, tolerability and pharmacokinetics (PK) of the novel compound in healthy volunteers, under fed and fasted conditions.

The expected total enrollment of 56 participants will consist of five single-ascending dose (SAD) cohorts and two multiple-ascending dose (MAD), each cohort involving eight participants randomized to six active and two placebo groups.

A patented New Chemical Entity (NCE), Lucid-MS is a neuroprotective compound with a novel mechanism of action for the treatment of MS, having shown to prevent myelin degradation (demyelination) and promote functional recovery in preclinical models. 

Current evidence suggests the novel compound is a non-immunomodulatory agent, which statedly is an important distinction in the potential for developing new, safe options for treating that specific health condition.

Lucid Psycheceuticals CEO Dr. Lakshmi Kotra said the trial’s safety review committee has recommended moving forward with the next cohort of dosing, which is expected to commence in the next few days.

Photo: Sam Moghadam Khamseh on Unsplash.