First participant completes dosing in Phase 1 Lucid-MS trial

Experimental oral med by FSD Pharma tested in healthy volunteer

by Margarida Maia, PhD | April 20, 2023

A handful of oral medications and a heart rate graph are used to highlight the words

The first participant has completed dosing in a Phase 1 clinical trial testing FSD Pharma‘s Lucid-21-302, an experimental oral medication for all types of multiple sclerosis (MS), in healthy volunteers.

After receiving a green light from Health Canada to launch the first-in-human trial, the company began by testing the medication in one person in advance of the full group of participants.

This is sometimes done to prevent unexpected side effects that might harm a group of participants all dosed at the same time. When this approach is used the very first person to receive the medication is called the sentinel subject.

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The trial is designed to test the safety and tolerability of Lucid-21-302, also known as Lucid-MS, in healthy people, a first step before moving into more advance trials in MS patients.

“Dosing the sentinel subject is a major achievement for our team and culmination of more than a decade of very promising research by a seasoned development team passionate about changing the future treatment paradigm for patients dealing with the debilitating effects of MS,” Lakshmi Kotra, said in a press release. Kotra is CEO of Lucid Psycheceuticals, a subsidiary of FSD Pharma.

In MS, the myelin sheath that protects the nerve fibers in the central nervous system (the brain and the spinal cord) becomes the target of an immune attack and becomes progressively damaged. This results in a range of symptoms, from muscle weakness to changes in sensation and fatigue.

Some treatments are available that can alter the disease course. Most of these medications, known as disease-modifying therapies (DMTs), are designed to tame the immune system, slowing the disease course and helping to prevent relapses.

However, because they keep the immune system in check, they can reduce the body’s ability to respond to infections and other types of insults.

Additionally, many DMTs require repeated under-the-skin (subcutaneous) or into-the-muscle (intramuscular) injections, and are available only for the treatment of relapsing, but not progressive, types of MS.

Lucid-MS is an oral therapy designed to ease the condition by preventing, or even repairing, the ongoing damage to myelin — while leaving the immune system untouched. According to FSD Pharma, it works by lowering a type of modification called citrullination on certain myelin-associated proteins, which seems to boost the immune reaction against myelin.

Earlier work done in a mouse model of MS showed that Lucid-MS restored motor function, indicating it was helping to repair myelin in damaged regions.

“Current MS treatments are immunomodulatory and include repeated subcutaneous or intramuscular injections for treating the symptoms of MS. We envision a day where an oral medication will protect or even help repair myelin in the central nervous system, a hallmark feature of the disease,” Kotra said.

“We are optimistic Lucid-MS has this type of paradigm-shifting potential and the sentinel dosing is a critical step in advancing this pipeline forward,” Kotra added.

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About the Author

Margarida Maia, PhD Margarida is a biochemist (University of Porto, Portugal) with a PhD in biomedical sciences (VIB and KULeuven, Belgium). Her main interest is science communication. She is also passionate about design and the dialogue between art and science.