Quantum BioPharma (NASDAQ: QNTM) has entered 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 Clinical Research Business.
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.
This development matters because it represents a potential breakthrough in treating progressive forms of MS, which currently have limited therapeutic options. By targeting PAD2, Lucid-MS aims to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis. Preclinical models have shown promise, and the Phase 2 trial will be the first to test this approach in humans. If successful, Lucid-MS could become a first-in-class treatment for MS, addressing a significant unmet medical need.
Quantum BioPharma is dedicated to building a portfolio of innovative assets for challenging neurodegenerative and metabolic disorders. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc., Quantum focuses on the research and development of Lucid-MS, a patented new chemical entity. The company also invented UNBUZZD and spun out its OTC version to Unbuzzd Wellness Inc., retaining a 19.84% ownership stake and royalty rights.
The SUA with Thermo Fisher, a global leader in clinical research services, lends credibility and operational expertise to the trial. Thermo Fisher's PPD business will manage study start-up activities, which include site selection, investigator recruitment, and regulatory preparations. This collaboration could accelerate the timeline for bringing Lucid-MS to patients.
For investors, this agreement signals progress in Quantum's pipeline and reinforces its commitment to advancing Lucid-MS. The latest news and updates relating to QNTM are available in the company's newsroom at https://ibn.fm/QNTM. To view the full press release, visit https://ibn.fm/CZH9U.
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