Quantum BioPharma gets FDA clearance to start Lucid-MS Phase 2 in progressive MS

Quantum BioPharma Ltd. said on August 10, 2026 that the U.S. Food and Drug Administration cleared the company's IND application for Lucid-MS (Lucid-21-302), allowing it to move the multiple sclerosis program into Phase 2 development.¹

The company said the clearance opens the regulatory pathway for a planned Phase 2 trial in progressive MS, and that it is working with a global clinical research organization experienced in neurodegenerative studies to help run the study.¹ It added that site selection is already underway and that it expects to begin enrolling patients and administering the drug as soon as possible.¹

Per the release, the Phase 2 trial is intended to measure efficacy through clinical and radiological markers tied to disability progression and disease biology, alongside safety and tolerability.¹ The company said Lucid-MS targets protein arginine deiminase 2 (PAD2), an enzyme linked to myelin breakdown, and that in preclinical models it prevented and reversed myelin damage.¹ It also noted that prior Phase 1 trials showed a favorable safety profile and good tolerability in healthy volunteers.¹

On financing, the company said its cash, digital assets, and liquid investments together exceeded $10 million as of March 31, 2026.¹

The release also referenced broader market data, saying the primary progressive MS treatment market is projected to grow from $1.16 billion in 2025 to $1.31 billion in 2026, a 13.7% compound annual growth rate, citing The Business Research Company, while the overall MS therapeutics market is estimated to reach about $38.62 billion by 2030 at a 5.93% CAGR, citing Grand View Research.¹

The statements above reflect the company's own characterizations of its data and market position; the release did not include independent verification of these figures or comparative trial results from other sponsors.