New therapy moves closer to Phase 2 testing in progressive MS
Thermo Fisher will support study start-up after FDA clearance to proceed
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Quantum Biopharma is working with Thermo Fisher Scientific to prepare a Phase 2 trial of Lucid-MS in people with progressive multiple sclerosis. (Image from iStock)
- Multiple sclerosis involves immune attacks that damage the protective myelin sheath around nerve fibers.
- Myelin loss disrupts nerve signals and can lead to problems with movement and other MS symptoms.
- An experimental oral therapy called Lucid-MS is advancing toward a Phase 2 clinical trial and is designed to prevent myelin loss.
Quantum Biopharma is collaborating with Thermo Fisher Scientific to prepare a Phase 2 clinical trial of Lucid-MS, an experimental oral therapy designed to slow myelin loss, in people with progressive forms of multiple sclerosis (MS).
Under the agreement, Thermo Fisher’s PPD clinical research business will support Quantum with study start-up activities and related clinical research services. Start-up work, including site selection, is already underway following recent clearance from the U.S. Food and Drug Administration (FDA), allowing Quantum to move forward with the trial.
The upcoming Phase 2 study will evaluate the safety, tolerability, and efficacy of Lucid-MS in people with progressive forms of MS. Progressive MS includes primary progressive MS (PPMS) and secondary progressive MS (SPMS).
“We are pleased to enter into a contract with the clinical research business of Thermo Fisher as we advance the Lucid-MS program toward Phase 2,” Zeeshan Saeed, Quantum’s CEO, said in a company press release. “Following FDA clearance to proceed with the Phase 2 study, initiating study start-up activities … represents an important next step.”
How MS damages myelin
MS is caused by misguided immune attacks that target the myelin sheath, a protective coating around nerve fibers that helps them transmit electrical signals more efficiently. The loss of myelin, known as demyelination, disrupts normal nerve communication, leading to a range of MS symptoms.
Most MS disease-modifying therapies work by suppressing or modulating immune activity, which can help reduce relapses and lesions and slow disease progression. However, these therapies generally cannot repair damaged myelin. Repairing myelin may help restore nerve signaling and improve some MS symptoms.
Lucid-MS, also known as Lucid-21-302, takes a different approach and is instead designed to prevent myelin damage. It works by blocking enzymes that become overactive in MS. These overactive enzymes alter myelin proteins in ways believed to make myelin more susceptible to autoimmune attacks.
“Lucid-MS is designed around a novel neuroprotective approach that targets demyelination rather than solely modulating the immune system,” said Andrzej Chruscinski, MD, PhD, Quantum’s president of scientific and clinical affairs. “The Phase 2 study will provide an important opportunity to evaluate this approach using clinical and radiological measures.”
The Phase 2 trial will mark the first time Lucid-MS is tested in people with MS. Earlier studies in mice and healthy volunteers supported moving the therapy into this next stage of testing.
In preclinical studies involving mice with MS-like symptoms, Lucid-MS treatment for about 50 days restored motor function to levels similar to those of healthy mice. The treatment was also reported to be safe and well tolerated in healthy volunteers after both a single dose and consecutive daily doses in two Phase 1 studies (NCT05821387 and NCT06595706).
“Our team brings deep experience in [central nervous system] and MS trials, along with an integrated approach that connects strategy and execution to help deliver these complex studies,” said Michael Cioffi, Thermo Fisher’s vice president and general manager of neuroscience and clinical research. “By combining scientific expertise with operational excellence, we can help bring promising new therapies closer to the patients who need them.”
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