Quantum BioPharma Ltd. (NASDAQ: QNTM), a biopharmaceutical company focused on developing innovative solutions for neurodegenerative and metabolic disorders, has announced a collaborative clinical study with scientists from Massachusetts General Hospital (MGH). The study aims to validate a novel positron emission tomography (PET) imaging technique, [18F]3F4AP PET, designed to monitor demyelination and myelin integrity in patients with multiple sclerosis (MS).
The study, led by Dr. Pedro Brugarolas of MGH’s Department of Radiology and Harvard Medical School, and co-investigator Dr. Eric Klawiter, director of the MS and Neuromyelitis Optica Unit at MGH, will explore the potential of [18F]3F4AP PET imaging as a biomarker for MS. This imaging method will be used alongside magnetic resonance imaging (MRI) in patients with both progressive and relapsing-remitting forms of MS.
Preclinical studies in rodents and monkeys have demonstrated that [18F]3F4AP PET is highly sensitive to demyelinated lesions. This suggests that the technique could serve as a valuable tool for tracking changes in demyelination in response to therapies aimed at remyelination or neuroprotection. Unlike traditional MRI, which provides structural imaging, [18F]3F4AP PET offers ultra-sensitive and quantitative assessments of demyelination.
Quantum BioPharma’s Vice President of Scientific and Clinical Affairs, Dr. Andrzej Chruscinski, emphasized the significance of this biomarker for future MS trials. “This novel PET biomarker has the potential to directly visualize and measure demyelination in the central nervous system,” he stated. “It aligns closely with our Lucid-MS clinical development program, which has shown promise in protecting the myelin sheath and preventing demyelination in preclinical models.”
Lucid-MS is Quantum BioPharma’s lead compound, developed through its subsidiary Lucid Psycheceuticals Inc. The drug candidate is a patented chemical entity designed to prevent and reverse myelin degradation, addressing one of the core mechanisms of multiple sclerosis.
Zeeshan Saeed, CEO of Quantum BioPharma, expressed enthusiasm about the collaboration: “We are thrilled to work with Mass General’s team of scientists and physicians on this study. Developing [18F]3F4AP as a biomarker could significantly advance how we evaluate MS treatments.”
Dr. Brugarolas explained that [18F]3F4AP is a radiolabeled form of dalfampridine, a drug approved for improving walking ability in MS patients, that binds to potassium channels exposed in demyelinated axons. By leveraging this mechanism, the tracer provides functional insights into demyelination rather than relying solely on structural imaging.
The inclusion of both progressive and relapsing-remitting MS patients is critical for understanding how biomarker sensitivity varies across disease subtypes. If successful, this imaging technique could transform MS clinical trials by offering more precise endpoints for evaluating remyelinating and neuroprotective therapies.
Quantum BioPharma Ltd., headquartered in Toronto, focuses on developing treatments for neurodegenerative disorders like MS, metabolic conditions, and alcohol misuse disorders. Its portfolio includes Lucid-MS, as well as strategic investments through its subsidiary FSD Strategic Investments Inc.
The company also retains ownership stakes in Celly Nutrition Corp., which markets UNBUZZD™, an over-the-counter product addressing alcohol misuse. Quantum BioPharma continues to develop pharmaceutical-grade formulations while maintaining royalty agreements tied to Celly Nutrition’s sales performance.
With this partnership with MGH scientists, Quantum BioPharma is positioning itself at the forefront of innovation in MS diagnostics and treatment development, a move that could redefine precision medicine for neurodegenerative diseases.
