Data: Lucid-MS seen to be safe, well tolerated in healthy volunteers

FSD Pharma’s Lucid-21-302 — an oral treatment candidate known as Lucid-MS, for all types of multiple sclerosis (MS) — was found safe and well tolerated across multiple doses in healthy volunteers, according to interim data from a Phase 1 clinical trial.

The newly released data are from the first four groups of participants who received a single ascending dose of the medication; however, no other details were shared by the company. Data from the fifth and final group are expected by the end of the month.

“Lucid-21-302 was demonstrated to be safe and well-tolerated in single oral doses in healthy volunteers,” Biopharma Services, the clinical research organization conducting the trial, said in the interim report.

Biopharma also added that levels reached by Lucid-MS in circulation, as well as its pharmacological properties across the four doses, “are very encouraging for further development activity.”

“We are thrilled with the results described in this report, and consider this to be a major milestone for our team,” Andrzej Chruscinski, PhD, vice-president of clinical and scientific affairs of Lucid Psycheceuticals, an FSD wholly-owned subsidiary that’s developing Lucid-MD, said in an FSD press release.

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Therapy aims to prevent, even reverse, myelin sheath damage

Lucid-MS is an experimental treatment designed to prevent, or even reverse, ongoing damage to the myelin sheath, the protective coat surrounding nerve cells that’s progressively lost in MS.

Myelin is necessary to protect nerve cells from damage and ensure neurons can rapidly transmit electric signals to neighboring cells. Its loss results in impaired nerve cell communication, which ultimately leads to disease symptoms.

Disease-modifying therapies available to MS patients can reduce the immune system responses that contribute to myelin damage, and thus slow disease progression.

But no treatments are available that can help to restore damaged myelin.

Such an effect on myelin could be beneficial for all types of MS, including for people with progressive forms of disease who have very few available therapies.

Lucid-MS aims to prevent, or even repair, myelin damage without interfering with the immune system. That’s important, as such interference can put patients at greater risk of infections or other side effects.

Preclinical data in a mouse model of MS showed that the compound lessened disease severity, helping animals with hind limb and tail paralysis fully recover their mobility after a few months of treatment.

“We are looking forward to continuing the development of Lucid-MS for potential treatment of progressive MS, an indication where there is an unmet need for novel, non-immunomodulatory treatments,” Chruscinski said.

Our objective in this [first-in-human] study was to determine the safety, tolerability, and pharmacokinetic profile of Lucid-MS in humans and we seem to have been successful in meeting those goals.

This first-in-human Phase 1 trial (NCT05821387), which dosed its first participant in April, was designed to assess how safe and well tolerated Lucid-MS is in healthy volunteers. It enrolled 40 participants, ages 18 to 60, who were given a single dose of the experimental therapy.

Patients were divided into five groups, in which increasing doses of the therapy were tested against a placebo. Eight participants were in each group, and all were randomly assigned to Lucid-MS (six patients) or a placebo (two patients).

“Our objective in this [first-in-human] study was to determine the safety, tolerability, and pharmacokinetic profile of Lucid-MS in humans and we seem to have been successful in meeting those goals,” said Lakshmi P. Kotra, CEO of Lucid Psycheceuticals.

“Development of novel, non-immunomodulatory therapies with new mechanisms of action is a very high priority for all stages of MS,” Kotra said, adding, “We are inspired to expeditiously pursue the next stages of clinical development to bring such novel therapies for patients.”

According to its therapy webpage, FSD Pharma has finished dosing the participants in the Phase 1 trial. The company also noted that its compound is patented.