Quantum BioPharma’s Lucid-MS, A Neuroprotective Multiple Sclerosis Drug, Clears Phase 1 Trial with Strong Safety Results

Quantum BioPharma Ltd., through its subsidiary Huge Biopharma Australia, has announced positive results from a Phase 1 clinical trial of Lucid-MS. The Clinical Study Report (CSR) confirmed that Lucid-MS was safe and well-tolerated in healthy adults who received multiple ascending daily doses. The randomized, double-blind, placebo-controlled study marks a major milestone in the drug's clinical development. 

“We are thrilled that we now have the CSR for the Phase 1 MAD trial and that Lucid-MS was found to be safe and well-tolerated in healthy participants. The CSR allows us to advance the clinical development of Lucid-MS as it is a critical component of the investigational new drug (IND) application with the FDA,” said Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs at Quantum BioPharma.

Lucid-MS is a novel, first-in-class neuroprotective compound designed for the treatment of multiple sclerosis (MS). Unlike traditional immunomodulatory therapies, Lucid-MS operates through a unique mechanism that does not modulate the immune system. Instead, it directly protects nerve cells by preventing demyelination, a key feature of MS and other neurodegenerative disorders.

“Results and observations from the first-in-human studies, including this MAD investigation, give us the confidence that Lucid-MS is safe and tolerable in healthy volunteers. Quantum team is preparing for the launch of efficacy trials in patients with MS, which is very exciting. This compound follows a novel non-immunomodulatory mechanism, and we are very excited to be planning human efficacy trials,” said Dr. Lakshmi P. Kotra, Director at Quantum BioPharma and a Professor at the University of Toronto, who led the discovery of Lucid-MS. 

As a patented New Chemical Entity (NCE), Lucid-MS represents a significant innovation in MS treatment. Preclinical data have shown the compound's ability to preserve the integrity of the myelin sheath around nerve fibers, offering a promising approach to slowing or preventing disease progression. These Phase 1 findings pave the way for further clinical evaluation in MS patients.