Quantum BioPharma Receives Final Reports for Two Key Studies of its Potential Breakthrough Drug for Multiple Sclerosis, Moving Closer to Phase 2 Clinical Trial

Executive Summary

• Quantum BioPharma received final reports for the 90‑day oral toxicity study and the toxicokinetic study of its lead MS candidate Lucid‑21‑302 (Lucid‑MS).
• The data will be used to support an Investigational New Drug (IND) application with the U.S. FDA for a Phase‑2 clinical trial in Multiple Sclerosis.
• Company executives highlighted the milestone as a significant step toward initiating the Phase 2 trial, underscoring the potential of Lucid‑MS as a first‑in‑class therapy for MS.

Key Details

• Study Reports Received:
• 90‑day oral toxicity study report for Lucid‑21‑302.
• Toxicokinetic (TK) study report for Lucid‑21‑302.
• Purpose of Studies: Provide key safety and pharmacokinetic data required for an IND filing with the U.S. FDA.
• Regulatory Path Forward: Data to be incorporated into Quantum’s IND submission, targeting initiation of a Phase 2 clinical trial in patients with Multiple Sclerosis.
• Executive Comments:
• Dr. Andrzej Chruscinski (VP, Scientific & Clinical Affairs) called the receipt of the reports an “important milestone.”
• Executive Co‑Chairman Anthony Durkacz expressed excitement about moving “significantly closer to initiating our Phase 2 trial.”
• Company Context: Lucid‑MS is a patented new chemical entity designed to prevent and reverse myelin degradation, the underlying mechanism of MS, demonstrated in preclinical models.

Notable Quotes

“We are pleased that we now have the final reports for these toxicity studies, as this represents an important milestone,” – Dr. Andrzej Chruscinski, Vice‑President, Scientific and Clinical Affairs.

“We are very excited about the potential of Lucid‑MS as a first‑in‑class treatment for MS… With these final reports, we move significantly closer to initiating our Phase 2 trial.” – Anthony Durkacz, Executive Co‑Chairman.