With new data, Quantum moves closer to launching trial of Lucid-MS
Developer calls its patented therapy a 'potential breakthrough drug' for MS
Quantum Biopharma says it is closer to initiating a Phase 2 clinical trial — one involving people living with multiple sclerosis (MS) — to test its experimental therapy Lucid-MS after receiving the final reports from two toxicology studies requested by the U.S Food and Drug Administration (FDA).
The studies will provide key data to support the company’s investigational new drug (IND) application, which will seek FDA clearance to launch clinical studies of Lucid-MS in the U.S.
The final toxicology data comprise reports from a 90-day oral toxicity study and a toxicokinetic study of Lucid-MS. Toxicokinetic studies track how a drug is absorbed, distributed, and cleared from the body, helping identify whether a medication could accumulate to harmful levels.
While results were not disclosed, these studies are key early steps in drug development, guiding the selection of safe dose ranges for clinical testing.
“We are pleased that we now have the final reports for these toxicity studies, as this represents an important milestone,” Andrzej Chruscinski, MD, PhD, Quantum’s vice president of clinical and scientific affairs, said in a company press release. “These reports will be used to support Quantum’s IND application to the U.S. FDA, further advancing the Lucid-MS drug development program.”
In MS, the immune system mistakenly targets the myelin sheath, an insulating layer that surrounds nerve fibers and enables efficient signal transmission. This process, known as demyelination, disrupts nerve communication and ultimately leads to a wide range of MS symptoms.
Lucid-MS, also known as Lucid-21-302, is being developed to prevent demyelination and promote myelin repair. If proven effective, the therapy has the potential to reverse nerve damage and restore some lost functions in people with MS — something that available MS treatments fail to achieve.
For its part, Quantum called its therapy candidate a “potential breakthrough drug for multiple sclerosis” in announcing the receipt of the toxicology reports.Lucid-MS uses different approach, aims to reverse disease progression
Lucid-MS takes different approach, aims to prevent myelin loss
Unlike conventional MS therapies that work mostly by suppressing immune activity — which increases the risk of infections and other side effects — Lucid-MS takes a different approach. The therapy works by inhibiting peptidyl arginine deiminases, a group of enzymes that are overactive in MS and make myelin more vulnerable to immune attacks.
According to Quantum, early preclinical research has shown that Lucid-MS has the ability to improve motor function and reduce symptom severity in MS animal models. In addition, the therapy has been deemed safe and well tolerated at single and multiple ascending doses in Phase 1 studies involving healthy volunteers.
“We are very excited about the potential of Lucid-MS as a first-in-class treatment for MS targeting demyelination,” said Anthony Durkacz, Quantum’s executive cochair. “With these final reports, we move significantly closer to initiating our Phase 2 trial of Lucid-MS in people with multiple sclerosis.”
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