Quantum inks agreement to prep filing for Lucid-MS Phase 2 trial
IND application to FDA expected to be completed by year's end
Quantum Biopharma has signed an agreement with a global pharmaceutical contract research organization to continue advancing Lucid-21-302, its experimental therapy for promoting myelin repair with multiple sclerosis (MS).
The collaboration will help the company put together an investigational new drug (IND) application for the therapy, which is also known as Lucid-MS. Expected by the end of 2025, the submission would seek the U.S. Food and Drug Administration’s (FDA) approval to launch a Phase 2 clinical trial of the therapy in people with MS.
“We are pleased to announce that we have signed this agreement to prepare the IND application package, which we hope to submit to the FDA in Q4 2025,” Zeeshan Saeed, CEO of Quantum, said in a company press release.
MS is caused by the immune system attacking the myelin sheath, a protective layer around nerve cells that facilitates their communication. The resulting myelin damage disrupts normal nerve signaling, causing disease symptoms.
A therapy that repairs myelin?
While several approved treatments can modify the course of MS and delay disability progression, these mostly work by reducing inflammation. To date, no therapy has been shown to help with myelin repair, which could potentially reverse some of the nerve damage and restore lost functions.
Lucid-MS is an experimental therapy Quantum is developing to prevent and possibly repair myelin damage, without suppressing the immune system, which can increase the risk of infections and other complications.
The patented medication works by blocking certain enzymes that are overactive in MS. These enzymes, called peptidyl arginine deiminases, induce protein modifications that can disrupt myelin structure and function and make it more susceptible to immune attacks.
Lucid-MS restored motor function and eased symptom severity in animal models of MS, which prompted the launch of two Phase 1 safety studies in healthy volunteers. Those now-completed studies tested single and multiple ascending doses of Lucid-MS, and data so far show the therapy is safe and well tolerated.
A 90-day study testing the toxicity and pharmacological effects of Lucid-MS was also conducted to support the IND application.
“This agreement takes us a step closer to initiating the phase 2 trial of Lucid-21-302, a first-in-class treatment for MS,” Saeed said.
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