Quantum Biopharma receives Lucid-MS study report

Executive Summary

• Quantum Biopharma announced the receipt of the Clinical Study Report (CSR) for the Phase 1 Multiple Ascending Dose (MAD) clinical trial of its experimental multiple sclerosis drug, Lucid-21-302 (Lucid-MS).
• The trial, conducted through subsidiary Huge Biopharma Australia Pty. Ltd., evaluated the safety and pharmacokinetics of Lucid-MS in healthy adult participants.
• The CSR concluded that Lucid-MS was safe and well-tolerated, with no safety or tolerability concerns identified, allowing the company to proceed with the Investigational New Drug (IND) application to the FDA.

Key Details

• Trial Name: "A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-MS in Healthy Adult Participants."
• Drug Mechanism: Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound and a patented new chemical entity.
• Preclinical Data: In preclinical models, Lucid-MS was shown to prevent demyelination, a hallmark of MS and other neurodegenerative diseases characterized by damage to the myelin sheath surrounding nerve fibers.
• Safety Outcome: The Phase 1 MAD trial found no safety or tolerability concerns following treatment with consecutive daily dosing of Lucid-MS in healthy participants.
• Regulatory Status: The CSR is a critical component of the Investigational New Drug (IND) application with the FDA.
• Next Steps: The company is preparing to launch efficacy trials in patients with MS.

Notable Quotes

• "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 application with the FDA." — Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs at Quantum Biopharma.
• "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... This compound follows a novel non-immunomodulatory mechanism, and we are very excited to be planning human efficacy trials." — Dr. Lakshmi P. Kotra, Director at Quantum Biopharma and Professor at the University of Toronto.