Quantum BioPharma Submits IND Application for Lucid-MS

Quantum BioPharma Ltd. has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lucid-MS, a new drug candidate for the treatment of multiple sclerosis (MS). This submission supports the planned Phase 2 clinical trial evaluating Lucid-MS's first-in-class therapeutic treatment targeting demyelination. The IND package includes data from nonclinical studies, manufacturing, and quality information. Subject to FDA clearance, the company intends to initiate the Phase 2 study as soon as possible, with anticipated FDA response in Q2 2026 and trial initiation planned for Q2 2026. Lucid-MS aims to provide neuroprotection by inhibiting demyelination, a key driver of MS progression. Phase 1 trials demonstrated a favorable safety profile. The company also highlighted its diversified business platform, including consumer health products and strategic investments, aimed at supporting continued research and development.