Quantum Biopharma to seek FDA OK for Phase 2 trial of Lucid-MS
Novel therapy designed to promote repair of damaged myelin in patients
Quantum Biopharma intends to ask the U.S. Food and Drug Administration (FDA) this year for permission to start a Phase 2 clinical trial testing Lucid-21-302, its novel therapy for promoting myelin repair, in people with multiple sclerosis (MS).
The company announced that it has completed dosing in a 90-day study testing the toxicity and pharmacological effects of Lucid-21-302 — also known as Lucid-MS. Results from that study are intended to support an investigational new drug application (IND), which is a formal request to the FDA seeking clearance to launch a clinical trial in the U.S. Quantum said it expects to submit the IND by the end of 2025.
“We are very pleased to have completed dosing in these toxicity studies as this advances the Lucid-21-302 drug development program. Reports from these studies will support an IND application, which we hope to submit before the end of the year,” Andrzej Chruscinski, MD, PhD, Quantum’s vice president of scientific and clinical affairs, said in a company press release.
Zeeshan Saeed, CEO of Quantum, added that “by completing these toxicity studies, we are now closer to initiating a Phase 2 trial of Lucid-21-302 in people with MS.”
Dosing now complete in toxicity study to support Phase 2 trial
MS is a chronic disorder marked by inflammation in the brain and spinal cord. This inflammation causes damage to the myelin sheath — a fatty covering that wraps around nerve fibers, protecting nerves and helping them to send electrical signals. In MS, damage to myelin disrupts normal nerve signaling, which ultimately leads to disease symptoms.
While many treatments for MS have won FDA approval, these therapies all work by inhibiting inflammation to reduce myelin damage. These medications have been proven to ease disease symptoms, but to date, no therapy has ever been shown to help promote myelin repair.
Theoretically, treatments to facilitate myelin repair could help to reverse the damage done by MS, not just slow the disease’s progression.
We are excited about potential of Lucid-21-302 as a new first-in-class treatment for multiple sclerosis.
Lucid-MS is a novel chemical entity that “has demonstrated in preclinical models to prevent and reverse myelin degradation,” according to Quantum’s website. The therapy specifically works by blocking the activity of peptidyl arginine deiminases, or PADs, which are proteins that help to control myelin structure and have been shown to be overactive in MS.
“We are excited about potential of Lucid-21-302 as a new first-in-class treatment for multiple sclerosis,” Saeed said.
Quantum did not provide any details about the design of the planned Phase 2 trial of Lucid-21-302 in MS. According to the company, the toxicity studies were conducted to support the planned IND filing with the FDA.
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