Clinical trial to test multiple Lucid-MS doses in healthy volunteers

FSD Pharma has entered an agreement to launch a Phase 1 clinical trial that will test multiple ascending doses of Lucid-21-302 — an oral treatment candidate commonly known as Lucid-MS, for all types of multiple sclerosis (MS) — in healthy volunteers.

The company’s subsidiary Huge Biopharma Australia established a collaboration with Ingenu CRO, a contract research organization, which will conduct the early-stage placebo-controlled clinical trial.

“We are very pleased to formalize this agreement and to collaborate with Ingenu to conduct this clinical study,” Zeeshan Saeed, co-chairman and CEO of FSD Pharma, said in a company press release.

Lucid-MS is designed to prevent damage to the myelin sheath, the fat-rich substance that wraps around nerve fibers and is essential for rapid nerve cell communication. In MS, inflammation in the brain and spinal cord causes damage to myelin, leading to the disease’s symptoms. This therapy aims to stop such damage from occurring — and even repair damaged myelin.

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Previous Phase 1 trial showed safety of Lucid-MS at single doses

The upcoming trial will build upon data from an earlier first-in-human Phase 1 trial (NCT05821387), in which healthy volunteers received single ascending doses of Lucid-MS.

A total of 40 participants, ages 18 to 60, were enrolled in that study and divided into five groups. Increasing doses of the medication were tested against a placebo across these groups to determine its safety and pharmacological properties.

The final results, shared by the company last month, demonstrated that the experimental therapy was safe and well tolerated at doses ranging from 50 to 300 mg. Further, its levels in the blood increased with exposure but were not affected by food intake.

No serious adverse events were reported, and most adverse events were deemed as unlikely related or unrelated to the experimental therapy.

“We are very eager to complete this clinical trial as efficiently as possible, and are encouraged by the strong data from the prior Phase 1 single ascending dose study supporting the safety and tolerability of Lucid-21-302,” said Andrzej Chruscinski, PhD, vice-president of clinical and scientific affairs at FSD Pharma.

“Over the next several days and weeks, our R&D [research and development] team will closely work with Ingenu to start this clinical study swiftly,” Chruscinski added.

We are very eager to complete this clinical trial as efficiently as possible, and are encouraged by the strong data from the prior Phase 1 single ascending dose study supporting the safety and tolerability of [Lucid-MS].

To date, more than 20 disease-modifying therapies have been approved to treat MS. However, these mostly work to curb inflammation and prevent more damage from occurring. None of these therapies is able to restore the damaged myelin.

Lucid-MS is designed both to prevent myelin damage and repair it, without affecting the immune system — which potentially could reduce the risk of infections or other side effects.

In a mouse model of MS, the therapy candidate was shown to lessen disease severity, helping mice with hind limb and tail paralysis recover their mobility in full after a few months of treatment.

Saeed said the new Phase 1 study will focus on Lucid-MS’ safety and efficacy with multiple ascending doses.

“This clinical study builds on our prior Phase 1 study of Lucid-21-302 and represents an important next step in our mission to develop novel therapeutics for the treatment of MS,” Saeed said.