FDA OKs first clinical trial testing novel oral therapy in MS patients

Following the submission of thousands of pages of documentation, the U.S. Food and Drug Administration (FDA) has given the green light for a mid-stage clinical trial of Lucid-MS, a potential first-in-class oral therapy for multiple sclerosis  (MS).

With the FDA’s clearance of an investigational new drug (IND) application from developer Quantum Biopharma, the therapy candidate will now be tested in people with MS for the first time. An earlier clinical trial had involved healthy adults.

Lucid-MS is a novel therapy designed to halt or even reverse MS disability progression by protecting myelin, the fatty sheath surrounding nerve fibers that is progressively damaged in the disease. According to the developer, the FDA decision marks an important milestone in its development.

“This is not just a regulatory checkpoint — it is a breakthrough moment to try to demonstrate, possibly for the first time, that neuroprotection is achievable,” Zeeshan Saeed, founder and CEO of Quantum, said in a company press release. “The approval from the FDA for Lucid-MS permits Quantum BioPharma to proceed with the Phase 2 clinical trial.”

Saeed noted that “the IND submitted was approximately 15,000 pages long.”

Trial start-up activities, including the selection of study sites, are already underway, per Quantum, with enrollment and dosing expected to begin as soon as possible. To support the study’s implementation, Quantum is working with Allucent, a global clinical research organization (CRO) with experience conducting studies in neurodegenerative diseases.

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MS occurs when the body’s immune system mistakenly attacks and damages the myelin sheath. This leads to myelin loss, or demyelination, and also triggers inflammation that gradually damages nerve cells, ultimately leading to MS symptoms.

Approved MS treatments primarily focus on suppressing the acute immune attacks that cause myelin damage. However, they cannot restore myelin that has already been lost and have more limited effects on the chronic inflammation that drives ongoing nerve damage and gradual disability worsening in progressive forms of MS.

Lucid-MS aims to restore lost function in patients

Lucid-MS, also known as Lucid-21-302, takes a different approach. Rather than suppressing the immune system, it blocks a group of enzymes that alter myelin proteins in ways believed to make the protective sheath more vulnerable to autoimmune attacks. By interfering with this process, Lucid-MS aims to prevent further demyelination and promote myelin repair.

This is expected not only to slow disease progression but also to potentially reverse some of the nerve damage seen in people with MS, which may help to restore lost functions.

“Progressive MS has long been an area of frustration for neurologists and patients alike, given the paucity of effective interventions,” said Andrzej Chruscinski, MD, PhD, vice president of scientific and clinical affairs at Quantum. “Lucid-MS offers a differentiated approach — it does not suppress the immune system but instead works to preserve myelin integrity and neuronal function. We believe this novel mechanism could fundamentally change how clinicians approach progressive MS.”

Preclinical studies in MS mouse models have shown that Lucid-MS has the ability to prevent myelin loss and promote its repair. The experimental treatment was also found to reduce symptom severity and improve motor function to levels comparable to those of healthy controls. In Phase 1 studies involving healthy adults, the therapy was deemed safe and well tolerated.

Lucid-MS represents a unique patented first-in-class, disease-modifying therapeutic opportunity in multiple sclerosis.

“The randomized, double-blind, placebo-controlled Phase 2 trial is intended to evaluate efficacy using clinical and radiological measures relevant to disability progression and disease biology, while also assessing safety and tolerability,” Chruscinski said. “This rigorous trial design meets the highest FDA standards and reflects our commitment to generating meaningful clinical data that can support a clear path toward regulatory submission and potential future approval.”

The study will also mark the first time Lucid-MS will be given to people with MS to assess whether treatment can restore lost functions, such as “loss of bodily control or mobility,” according to Quantum.

According to Saeed, “Lucid-MS represents a unique patented first-in-class, disease-modifying therapeutic opportunity in multiple sclerosis by targeting demyelination, particularly in progressive forms of the disease where unmet medical needs remain today.”