Quantum says it will work with agency to address issues raised
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The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Quantum Biopharma’s application seeking clearance to begin a Phase 2 trial testing Lucid-MS in people with multiple sclerosis (MS).
Quantum said the FDA requested further information before clearing the investigational new drug (IND) application and allowing the study to proceed. The company didn’t disclose the agency’s specific concerns.
“We are committed to working constructively with the FDA to address the comments raised and to advancing Lucid-MS responsibly for people living with MS,” Andrzej Chruscinski, MD, PhD, Quantum’s vice president of clinical and scientific affairs, said in a company press release. “We believe the matters identified by the FDA are fully addressable and intend to work collaboratively with the agency to resolve the comments raised in the clinical hold letter.”
The clinical hold comes about two months after Quantum submitted the IND seeking FDA clearance for the Phase 2 trial to evaluate the treatment’s safety and tolerability in people with MS, while exploring its potential to slow disease progression.
As a result of the FDA’s decision, Quantum has withdrawn previously announced timelines for regulatory review, trial initiation, and interim data reporting, noting that future development plans will depend on ongoing regulatory interactions. The company said it is working with advisors and development partners, and plans to submit a formal response package after reviewing the FDA’s comments and completing related activities.
Lucid-MS is an oral therapy designed to protect myelin, the fatty coating that surrounds nerve fibers and helps them transmit electrical signals. In MS, damage to this sheath in the brain and spinal cord disrupts communication between nerve cells, contributing to symptoms and disease progression.
Unlike approved disease-modifying therapies, which mainly work by reducing the immune responses that drive myelin damage, Lucid-MS is intended to protect myelin directly and potentially promote its repair.
The therapy targets a family of enzymes that become overactive in MS and are thought to make myelin more vulnerable to autoimmune attacks. By inhibiting their activity, Lucid-MS is designed to prevent myelin damage, which is expected to slow disease progression and potentially restore lost functions.
The therapy has shown encouraging results in mouse models of MS, in which treatment reduced disease severity and improved motor function to levels comparable to those of healthy animals. Lucid-MS has also been deemed safe and well tolerated at single and multiple doses in two Phase 1 studies involving healthy volunteers.
To support its IND application, Quantum also completed two toxicology studies requested by the FDA, including a 90-day oral toxicity study and a toxicokinetic study, which examines how a therapy is absorbed, distributed, metabolized, and eliminated by the body. While the company included the findings in its regulatory submission, it did not disclose detailed results.
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