Quantum BioPharma receives FDA clearance for Lucid-MS Phase 2 trials

Quantum BioPharma has received FDA approval for its Investigational New Drug application for Lucid-MS (Lucid-21-302), allowing the candidate to proceed to Phase 2 clinical development for multiple sclerosis (MS).

Unlike current MS therapies that focus on immune system modulation to reduce inflammation, Lucid-MS aims to provide neuroprotection by targeting the protein arginine deiminase 2 (PAD2) enzyme. This mechanism is designed to inhibit demyelination, which preclinical models suggest could prevent or even reverse myelin breakdown.

The upcoming Phase 2 study will be a randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of the drug using clinical and radiological measures. Trial start-up activities, such as site selection, are currently underway, with patient enrollment expected to begin shortly. Previous Phase 1 trials in healthy participants indicated the candidate was well tolerated.