Health Canada clears Phase 1 trial of Lucid-MS in healthy volunteers

FSD Pharma will soon launch a first-in-human trial testing Lucid-21-302, known as Lucid-MS — its novel chemical treatment for multiple sclerosis (MS) — in healthy volunteers.

Health Canada has cleared the company to initiate a Phase 1 clinical trial of the investigational therapy, FSD Pharma announced in a press release.

The green light comes just a few weeks after the company submitted an application to the regulatory agency asking to start testing Lucid-MS in humans. The treatment had shown promise in animal models of the disease.

Lucid-MS is a new chemical entity proposed to treat all forms of MS. The upcoming study will first investigate the safety and tolerability of the compound in healthy people.

“We are excited to receive … regulatory clearance, and look forward to initiating the first clinical trial of this promising candidate as a critical steppingstone in our mission to develop novel therapeutics for the treatment of MS,” said Lakshmi Kotra, PhD, CEO of Lucid Psycheceuticals, a subsidiary of FSD Pharma.

MS occurs when the immune system mistakenly attacks the myelin sheath, a fatty protective coating around nerve fibers that is essential for efficient nerve cell communication. This results in inflammation that damages myelin and nerve cells, disrupting nerve signaling and leading to disease symptoms.

Most approved therapies for MS work by reducing the activity of the immune system to dampen inflammation. However, these therapies also lower the patient’s ability to fight off infections, which is a major drawback due to the risk of side effects.

“There is an acute need today for effective, non-immunomodulatory, neuroprotective therapeutics, especially for the treatment of progressive stages of MS,” Kotra said.

FSD Pharma developed Lucid-MS to treat the neurodegenerative disease via a distinct mechanism. The compound works by reducing the citrullination of myelin-associated proteins. This is a protein modification process in which the amino acid arginine is converted into citrulline; amino acids are the building blocks of proteins.

Although this modification is required for the normal function of certain proteins, research has shown that MS patients have an increase in myelin citrullination and that this results in a greater immune reaction against myelin.

By lowering myelin citrullination, Lucid-MS was found in animal models of MS to prevent myelin degradation and promote functional recovery. Now, FSD Pharma will test the product in humans.

We … look forward to initiating the first clinical trial of this promising candidate as a critical steppingstone in our mission to develop novel therapeutics for the treatment of MS.

FSD Pharma has been developing Lucid-MS for 11 years, and evidence shows the treatment exerts its action without suppressing the immune system. According to the company, that makes it a potential therapeutic option for MS.

“Our drug development team worked hard to advance this pipeline into clinical stages,” said Andrzej Chruscinski, MD, PhD, vice president, clinical and scientific affairs at Lucid Psycheceuticals.

“We continue to evaluate our clinical development strategy to advance Lucid-MS into next phases of development efficiently in collaboration with our expert advisors,” Chruscinski added.