Quantum prepares for Phase 2 trial of oral therapy Lucid-MS
Company signs manufacturing contract for myelin-repairing treatment
An oral treatment that could repair nerve damage in multiple sclerosis (MS) is a step closer to a Phase 2 clinical trial.
Quantum Biopharma signed a manufacturing agreement covering an oral formulation of its investigational small molecule Lucid-21-302, also known as Lucid-MS, as it prepares for the Phase 2 clinical trial to test the drug in MS.
The company said it signed an agreement with a “leading” contract development and manufacturing organization to produce the drug.
Quantum is also collaborating with a global pharmaceutical contract research organization to prepare an application seeking clearance to start the Phase 2 clinical trial. It expects to file the investigational new drug application with the U.S. Food and Drug Administration by the end of this year.
The manufacturing agreement is “an important step in the clinical development of Lucid-MS,” Andrzej Chruscinski, MD, PhD, Quantum’s vice president of clinical and scientific affairs, said in a company press release.
Promoting myelin repair without involving immune system
In MS, the body erroneously launches an immune attack against the myelin sheath, a protective covering around nerve cells that helps them send electrical signals more efficiently. Loss of myelin, or demyelination, interferes with nerve transmission and causes nerve cell damage, leading to a range of MS symptoms.
Lucid-MS aims to prevent demyelination and promote myelin repair (remyelination), something that current treatments generally fail to achieve. This could potentially reverse some of the nerve damage and restore lost functions.
While most MS treatments work by suppressing the immune system, which can increase the risk of infections and other complications, Lucid-MS does not act on the immune system.
The therapy is designed to block certain enzymes, known as peptidyl arginine deiminases, which are overactive in MS and make myelin more susceptible to immune attacks.
According to Quantum, preclinical studies support the efficacy of Lucid-MS in MS, showing it can help restore motor function and ease symptom severity in animal models of the disease. Data from prior Phase 1 trials involving healthy participants also supported the therapy’s safety and tolerability at single and multiple ascending doses.
About the Author
