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Quantum Biopharma completes dosing in Lucid-MS studies

By The Northwire Desk — AI Analysis Dec 23, 2025 · 16:04 QNTM · 14.50 Quantum Biopharma Ltd
QNTM · Price

Executive Summary

  • Quantum Biopharma Ltd. has completed oral dosing for both the 180-day repeated dose oral toxicity and toxicokinetic studies for its lead drug candidate, Lucid-21-302 (Lucid-MS).
  • These completed studies are critical components required to support the Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).
  • The completion of these studies positions the company two steps closer to initiating a Phase 2 clinical trial of Lucid-MS in patients with multiple sclerosis (MS).

Key Details

  • Study Completion: Oral dosing is complete for the 180-day chronic toxicity and toxicokinetic studies for Lucid-21-302 (Lucid-MS).
  • Regulatory Impact: Data from these studies will support the upcoming IND application to the FDA.
  • Clinical Pipeline: The data is intended to support the design of a Phase 2 trial for Lucid-MS in people with multiple sclerosis.
  • Drug Mechanism: Lucid-MS is a patented new chemical entity designed to prevent and reverse myelin degradation, the underlying mechanism of MS, based on preclinical models.
  • Corporate Structure & Royalties:
    • Quantum Biopharma retains a 19.86% ownership stake in Unbuzzd Wellness Inc. (formerly Celly Nutrition Corp.), which holds the rights to the OTC product "unbuzzd."
    • The agreement includes a 7% royalty on unbuzzd sales until Quantum Biopharma receives $250 million in total payments.
    • After the $250 million threshold is reached, the royalty rate drops to 3% in perpetuity.
    • Quantum Biopharma retains 100% of the rights to develop similar products or alternative formulations for pharmaceutical and medical uses.

Notable Quotes

  • "We are very pleased that dosing is now complete in both 180-day chronic toxicity studies. These studies allow us to advance the Lucid-MS drug development program as they are critical components to the IND application with the FDA." — Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs
  • "By completing these 180-day toxicity studies, we are now two important steps closer to initiating the phase 2 trial of Lucid-MS in people with multiple sclerosis. We are very excited about the potential of this new, first-in-class treatment to prevent disease progression and inhibit demyelination in MS." — Anthony Durkacz, Founder and Executive Co-Chairman
Read the original news release →

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