newsfilter
← Latest News
GlobeNewswire·

Quantum BioPharma Receives United States FDA Clearance To Proceed with Lucid-MS Phase 2 Trial in Progressive Multiple Sclerosis:

QNTM
  • Quantum BioPharma received FDA approval for its Investigational New Drug (IND) application for Lucid-MS (Lucid-21-302), enabling immediate initiation of Phase 2 clinical trials.
  • The upcoming Phase 2 study will be a randomized, double-blind, placebo-controlled trial targeting progressive multiple sclerosis patients to evaluate the drug's ability to reverse loss of bodily control or mobility.
  • Lucid-MS is a patented, first-in-class neuroprotective therapy designed to inhibit demyelination by targeting protein arginine deiminase 2 (PAD2) rather than suppressing the immune system.
  • Trial start-up activities, including site selection, are currently underway with a leading global clinical research organization, and patient enrollment is expected to begin as soon as possible.
  • The company reports a strong financial position with over USD $10 million in cash, digital assets, and liquid investments as of March 31, 2026.
  • Lucid-MS follows a favorable safety profile established during Phase 1 trials in healthy participants, where it was well-tolerated.
  • The company retains ownership of 19.84% of Unbuzzd Wellness Inc. and receives royalty payments starting at 7% of sales until a $250 million cap is reached.
  • Market analysis projects the PPMS treatment market to reach USD $1.31 billion by 2026, while the global MS therapeutics market is anticipated to hit approximately USD $38.62 billion by 2030.
  • The announcement coincides with renewed investor confidence in the neurology sector, highlighted by a 6.33% gain in the BioWorld Neurological Diseases Index in 2025.