Myelin-targeting drug Lucid-MS inches closer to testing in patients
Developer Quantam completes 2 FDA-requested toxicology studies
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- Lucid-MS, an experimental drug for multiple sclerosis, targets myelin loss.
- Developer Quantum Biopharma has now completed two FDA-requested toxicology studies testing the oral therapy.
- The results are expected to support the launch of a Phase 2 trial testing the drug in MS patients.
Quantum Biopharma has completed dosing in two toxicology studies requested by the U.S. Food and Drug Administration (FDA) that aim to support the launch of clinical studies of Lucid-MS, an experimental treatment for multiple sclerosis (MS) that’s designed to slow myelin loss.
The 180-day toxicity and toxicokinetic studies were designed to evaluate any potential harmful effects of Lucid-MS and track how the medication is absorbed, distributed, and cleared from the body, helping identify the risk of toxic buildup.
The company did not provide details on the results of these studies, but said the data are expected to support an investigational new drug (IND) application to the FDA, requesting permission to initiate a Phase 2 trial of Lucid-MS in people with MS.
“We are very pleased that dosing is now complete in both 180-day chronic toxicity studies. These studies allow us to advance the Lucid-MS drug development program as they are critical components to the IND application with the FDA,” Andrzej Chruscinski, MD, PhD, vice president of clinical and scientific affairs at Quantum, said in a company press release.
MS is a chronic disorder marked by inflammation that damages myelin in the brain and spinal cord. Myelin is a fatty substance that wraps around nerve fibers and helps them send electrical signals, a bit like rubber insulation around a metal wire. In MS, damage to myelin disrupts nerve signaling, leading to disease symptoms.
Lucid-MS aims to reduce myelin loss to slow disease progression
Currently available MS treatments aim to slow disease progression by dampening inflammation. Lucid-MS, also known as Lucid-21-302, takes a different approach.
The investigational oral therapy works by inhibiting enzymes called peptidyl arginine deiminases that play a role in myelin loss. By blocking these enzymes, Lucid-MS aims to reduce myelin loss and promote myelin repair, which could ultimately reverse some of the nerve damage seen in MS patients and restore lost functions.
In a clinical trial involving healthy volunteers, Lucid-MS showed a favorable safety profile. For months, Quantum has been preparing to apply for FDA permission to start testing the therapy in MS patients.
By completing these 180-day toxicity studies, we are now two important steps closer to initiating the Phase 2 trial of Lucid-MS in people with multiple sclerosis.
“We are very excited about the potential of this new, first-in-class treatment to prevent disease progression and inhibit [myelin loss] in MS,” Anthony Durkacz, founder and executive cochairman of Quantum, said in announcing completion of the two studies, which each spanned about six months.
“By completing these 180-day toxicity studies, we are now two important steps closer to initiating the Phase 2 trial of Lucid-MS in people with multiple sclerosis,” Durkacz said.
