Quantum Biopharma seeks FDA clearance to test Lucid-MS in patients
Phase 2 trial will assess if therapy can stop demyelination and slow MS
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Quantum Biopharma has asked the FDA to approve a Phase 2 clinical trial for its therapy Lucid-MS. (Photo by iStock)
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Quantum Biopharma seeks FDA clearance for Lucid-MS, an oral therapy for multiple sclerosis.
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Lucid-MS aims to halt multiple sclerosis progression by protecting nerve myelin from damage.
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A Phase 2 trial will assess Lucid-MS's safety and effectiveness in human patients.
Quantum Biopharma has officially filed with the U.S. Food and Drug Administration (FDA) for clearance to begin a Phase 2 clinical trial of Lucid-MS, a “first-in-class” oral therapy designed to halt the progression of multiple sclerosis (MS) by protecting myelin, or the protective sheath around nerves in the brain.
The Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration includes a comprehensive data package covering pharmacology, toxicology, and manufacturing quality. If cleared, the company intends to launch the Phase 2 study as soon as possible to evaluate the treatment’s safety and effectiveness in human patients.
“This IND submission is supported by a comprehensive preclinical research package designed to characterize the safety profile of Lucid-MS,” said Andrzej Chruscinski, MD, PhD, vice-president of scientific and clinical affairs at Quantum, said in a company press release. “The data we’ve compiled reflects many years of dedicated scientific research.”
Partnering for clinical execution
The trial aims to measure how well the therapy is tolerated and whether it successfully prevents disease progression in those living with MS. To manage the logistics of this upcoming study, Quantum has signed a binding letter of intent with Allucent, a global clinical research organization (CRO) specializing in central nervous system trials.
Allucent will oversee site selection, patient recruitment, and data analysis. Zeeshan Saeed, CEO of Quantum, noted in another press release that Allucent’s prior experience in MS studies will be vital to the “efficient execution” of the trial. The companies expect to finalize a full services agreement in the coming weeks.
MS is marked by inflammation in the brain and spinal cord that damages the myelin sheath, a fatty coating around nerve fibers that is essential for proper nerve signal transmission.
Current MS treatments primarily focus on dampening the immune system to reduce inflammation and prevent further damage. While they may help slow disease progression, these therapies generally cannot repair the myelin sheath — the fatty protective coating around nerve fibers — once it has been compromised.
Lucid-MS takes a different approach. It works to inhibit enzymes that alter myelin proteins in ways that are believed to make myelin more susceptible to autoimmune attacks. This is expected to prevent myelin damage and slow or halt disease progression.
“Lucid-MS is a first-in-class, new chemical entity, therapeutic innovation designed to provide neuroprotection through the inhibition of demyelination, a key driver of disease progression in MS,” Chruscinski said.
The move to Phase 2 follows promising results in both animal models and early human testing. In preclinical studies involving mice with MS-like symptoms, Lucid-MS not only reduced disease severity but also restored motor function to levels comparable to those of healthy controls. At the end of follow-up, the animals recovered completely and behaved similarly to a healthy mouse.
The therapy has also completed Phase 1 trials in healthy volunteers. During those studies, Lucid-MS was reported to be safe and well tolerated across various dose levels, helping to clear the path for the company to test its efficacy in the MS patient population.
