Quantum seeks faster UK access for MS therapy Lucid-MS
Treatment aims to promote myelin repair without damaging immune system
Quantum Biopharma filed a U.K. innovation passport application to streamline the development and review of Lucid-21-302 (Lucid-MS), a therapy designed to promote myelin repair in people with multiple sclerosis (MS).
The submission, made via Quantum’s Australian subsidiary, Huge Biopharma Australia, marks the first step to entering the U.K.’s Innovative Licensing and Access Pathway (ILAP), a regulatory program aimed at accelerating the development and approval of therapies that address unmet medical needs. The goal is to help bring transformative treatments to patients more quickly.
“We are excited about the possibility that the ILAP Program could accelerate drug development, regulatory approval and, most importantly, patient access to this exciting, new potential MS treatment in the UK.,” Andrzej Chruscinski, MD, PhD, Quantum’s vice president of scientific and clinical affairs, said in a company press release.
The program would allow Quantum to collaborate more closely with key U.K. regulatory bodies and health authorities as well as patients, providing access to early and frequent scientific advice, supporting development of a roadmap for early access, and offering prioritized access to certain services.
MS is caused by the immune system attacking the myelin sheath, a fatty layer that insulates nerve fibers and helps them send signals efficiently. The resulting myelin damage disrupts communication between nerve cells, ultimately causing MS symptoms.
MS therapy promotes myelin repair without immune damage
Most approved MS disease-modifying therapies work by reducing immune system responses to help prevent further myelin damage. While these therapies can ease disease symptoms and slow progression, they do not repair nerve damage or restore lost functions. Due to their immunosuppressive effects, they also often carry an increased risk of infections and other complications.
Lucid‑21‑302 is a patented chemical entity that aims to protect existing myelin and promote its repair without interfering with the immune system.
The compound works by blocking the activity of enzymes called peptidyl arginine deiminases, or PADs, which are overactive in MS. These enzymes modify proteins in the myelin sheath, disrupting the myelin structure and making it more susceptible to immune attacks.
In preclinical studies using a mouse model of MS, Lucid‑21‑302 was shown to restore motor function and ease symptom severity. The therapy has also been evaluated in two Phase 1 safety studies, designed to assess single and multiple ascending doses of Lucid‑21‑302 in healthy volunteers. Data so far show the therapy is safe and well tolerated.
Quantum has completed a toxicity and pharmacology study to support an application with the U.S. Food and Drug Administration (FDA) seeking clearance to launch a Phase 2 clinical trial in people with MS. The company is working with a global pharmaceutical contract research organization to prepare the application, which it expects to file with the FDA later this year.
About the Author
