Quantum BioPharma (NASDAQ: QNTM) entered into a Study Start-Up Agreement (“SUA”) with the clinical research business of Thermo Fisher Scientific to implement its Phase 2 clinical trial of Lucid-21-302 (“Lucid-MS”) for multiple sclerosis (“MS”). The agreement initiates formal study start-up activities following FDA clearance to proceed with the trial. Thermo Fisher will support study start-up and related clinical research services through its PPD(TM) Clinical Research Business.
Quantum BioPharma said the randomized, double-blind, placebo-controlled Phase 2 trial will evaluate the efficacy, safety and tolerability of Lucid-MS in people with progressive forms of MS using clinical and radiological endpoints. Lucid-MS is an investigational, first-in-class New Chemical Entity designed to provide neuroprotection by inhibiting demyelination through targeting protein arginine deiminase 2 (“PAD2”), an enzyme implicated in myelin degradation.
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About Quantum BioPharma Ltd.
Quantum is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), Quantum is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum invented UNBUZZD(TM) and spun out its OTC version to a company, Unbuzzd Wellness Inc. (“Unbuzzd”) (formerly, Celly Nutrition Corp.), led by industry veterans. Quantum retains ownership of 19.84% (as of March 31, 2026) of Unbuzzd at www.unbuzzd.com. The agreement with Unbuzzd also includes royalty payments of 7% of sales from unbuzzd(TM) until payments to Quantum total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses.
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In brief
Quantum BioPharma says it has signed a study start-up agreement with Thermo Fisher Scientific’s clinical research business to prepare a Phase 2 trial of Lucid-MS, also identified as Lucid-21-302, for multiple sclerosis. The agreement follows FDA clearance to proceed and covers start-up work and related clinical research services provided through PPD Clinical Research Business. The company describes the planned study as randomized, double-blind and placebo-controlled, with evaluation of efficacy, safety and tolerability in people with progressive forms of MS. It says assessments will use clinical and radiological endpoints. Lucid-MS is an investigational compound intended to target PAD2, an enzyme the release links to myelin degradation. The announcement does not provide a trial start date or enrollment target.
Key takeaways
- Quantum BioPharma signed a study start-up agreement with Thermo Fisher Scientific’s clinical research business.
- The agreement supports preparations for a Phase 2 Lucid-MS trial after FDA clearance to proceed.
- The company says the study will assess efficacy, safety and tolerability in people with progressive MS.
- The planned trial is randomized, double-blind and placebo-controlled, with clinical and radiological endpoints.
SEC filings
Earlier from Quantum BioPharma Ltd.
- Quantum BioPharma (NASDAQ: QNTM) Receives FDA Green Light to Move Lucid-MS into Phase 2 Testing
- Quantum BioPharma (NASDAQ: QNTM) Pursues a New Path for Better Multiple Sclerosis Treatments
- Quantum BioPharma (NASDAQ: QNTM) to Present at 3rd Annual ArcStone-Kingswood Growth Summit
- Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM) Advances Myelin-Protecting MS Therapy as Treatment Paradigm Evolves
- Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM) Reports Lower Q2 Expenses, Advances Lucid-MS Into Phase 2
