Mr. Zeeshan Saeed reports
QUANTUM BIOPHARMA SIGNS BINDING LETTER OF INTENT WITH ALLUCENT TO CONDUCT PHASE 2 CLINICAL TRIAL IN MULTIPLE SCLEROSIS
Quantum Biopharma Ltd. has entered into a binding letter of intent (LOI) with Allucent, a global contract research organization with extensive experience supporting central nervous system clinical trials, to support the planned phase 2 clinical trial of Lucid-MS for the treatment of multiple sclerosis (MS).
This strategic partnership represents a significant milestone in Quantum Biopharma's clinical development pipeline and underscores the company's commitment to advancing a potentially innovative solution for those MS patients suffering from debilitating mobility conditions unlike any solution in the market today.
The planned phase 2 trial will evaluate the efficacy, safety and tolerability of Lucid-MS in people with MS. Quantum Biopharma expects to initiate the phase 2 trial in the second quarter of 2026, subject to regulatory approvals and finalization of the clinical trial design and operational arrangements.
Under the terms of the LOI, Allucent will provide comprehensive clinical trial services designed to support efficient execution and data integrity throughout the study as shown in the attached table.
The parties will finalize a more comprehensive and definitive services agreement in the coming weeks, solidifying this strategic partnership.
First-in-class potential therapeutic innovation for MS
Lucid-MS is designed to provide neuroprotection through the inhibition of demyelination -- a key driver of disease progression in MS. This innovative mechanism represents a differentiated therapeutic approach in the global MS market, where many existing treatments primarily focus on modulating the immune system rather than addressing the underlying neurodegeneration.
"Lucid-MS is a first-in-class, new chemical entity, therapeutic innovation designed to provide neuroprotection through the inhibition of demyelination, a key driver of disease progression in MS," said Andrzej Chruscinski, vice-president, scientific and clinical affairs, at Quantum Biopharma. "This innovative mechanism represents a differentiated therapeutic approach in the global MS market where an estimated 2.8 million people suffer and where many existing treatments primarily focus on modulating the immune system rather than addressing the underlying neurodegeneration. This phase 2 trial will evaluate efficacy, safety and tolerability, while exploring the relationship between this mechanism and established clinical and radiographic markers of disease activity."
"We are pleased to engage Allucent, a global CRO with extensive experience in phase 2 and phase 3 central nervous system trials, including prior MS studies, as we advance our clinical program," said Zeeshan Saeed, chief executive officer of Quantum Biopharma. "Their therapeutic expertise and global operational capabilities are expected to support the efficient execution of our phase 2 trial. Our research continues to demonstrate the potential of this novel approach to transform MS patient outcomes."
Why Allucent: global CRO excellence
Allucent is a global, specialty contract research organization designed for small and mid-sized biopharma, delivering integrated clinical, regulatory and operational expertise across complex programs, including neuroscience. Their proven record in CNS and MS trials makes them an ideal partner for advancing Lucid-MS through phase 2.
"We're proud to partner with Quantum Biopharma in advancing their neuro-degenerative clinical program in multiple sclerosis," said Paula Brown Stafford, chief executive officer of Allucent. "Our team brings deep experience in CNS and MS trials, along with an integrated model that aligns strategy and execution, helping ensure programs are delivered efficiently and with the rigor these complex studies demand."
Market opportunity and growth strategy
Multiple sclerosis affects approximately 2.8 million people worldwide, representing a significant global
health care challenge and substantial market opportunity for innovative
treatments. The MS therapeutic
market is projected to exceed $38-billion by 2030 according to Grand View Research.
Quantum Biopharma's differentiated approach -- targeting demyelination directly -- positions Lucid-MS to address current unmet patient needs and potentially capture meaningful market share in the emerging neuroprotective segment.
About Quantum Biopharma Ltd.
Quantum Biopharma 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., Quantum Biopharma 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 Biopharma invented unbuzzd and spun out its OTC version to a company, Unbuzzd Wellness Inc., led by industry veterans. Quantum Biopharma retains ownership of 19.84 per cent (as of Dec. 31, 2025) of UWI. The agreement with UWI also includes royalty payments of 7 per cent of sales from unbuzzd until payments to Quantum Biopharma total $250-million. Once $250-million is reached, the royalty drops to 3 per cent in perpetuity. Additionally, Quantum Biopharma retains a large tax loss carry forward of approximately $130-million and could be utilized in the future to offset tax payable obligations against future profits. Quantum Biopharma retains 100 per cent of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses. Quantum Biopharma maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property.
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