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Quantum Biopharma Announces Completion of Dosing in 180-Day Repeated Dose Oral Toxicity and Toxicokinetic Studies for Lucid-21-302 (Lucid-MS)

By The Northwire Desk — AI Analysis Dec 23, 2025 · 08:00 QNTM · 14.5 Quantum BioPharma Ltd.
QNTM · Price

Executive Summary

  • Quantum BioPharma completed oral dosing in both 180‑day chronic toxicity and toxicokinetic studies for Lucid‑MS (Lucid‑21‑302).
  • The data from these studies will be used to support the company’s Investigational New Drug (IND) application with the U.S. FDA and to design a Phase 2 trial in multiple sclerosis patients.
  • Completion of the toxicity program moves the program two major milestones closer to initiating human Phase 2 testing, representing a material positive development for the company’s lead asset.

Key Details

  • Oral dosing of Lucid‑MS is now complete in both 180‑day chronic toxicity and toxicokinetic studies.
  • Results from these studies will be incorporated into the IND filing with the FDA.
  • The IND data package will also inform the design (dose, schedule, safety monitoring) of a planned Phase 2 clinical trial in people with multiple sclerosis (MS).
  • Dr. Andrzej Chruscinski, VP Scientific & Clinical Affairs, highlighted that completing dosing “allows us to advance the Lucid‑MS drug development program as they are critical components to the IND application.”
  • Founder and Executive Co‑Chairman Anthony Durkacz noted the studies bring the company “two important steps closer to initiating the Phase 2 trial” and expressed excitement about the potential of this first‑in‑class therapy to prevent disease progression and inhibit demyelination in MS.

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

Materiality Assessment: Material – Positive**. The completion of pivotal preclinical studies materially advances the lead program toward regulatory filing and clinical testing, a positive catalyst for the company’s valuation.

Read the original news release →

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