AUSTIN, Texas, June 22, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Multiple sclerosis (“MS”) robs people of control over their own bodies — slowly, relentlessly and without a cure. More than 2.9 million people worldwide are living with MS today, and despite decades of research, every approved treatment falls short of the same fundamental goal: stopping the disease cold. Current therapies can slow progression, but they cannot halt it, and for millions of patients, that gap means a future of worsening disability. Now, Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (profile) is challenging that reality. The company is advancing Lucid-MS, a patented, first-in-class drug candidate that takes a fundamentally different approach by directly targeting the myelin sheath that MS destroys, and this new drug candidate is preparing to enter phase 2 clinical trials. Quantum BioPharma is one of several companies focused on the development and commercialization of therapies for neurological, autoimmune and immune-mediated diseases, including Sanofi (NASDAQ: SNY), Roche Holding AG (OTCQX: RHHBY), Biogen Inc. (NASDAQ: BIIB) and Clene Inc. (NASDAQ: CLNN).

• What makes MS particularly devastating is its progressive nature.
• Rather than targeting the immune system, Quantum BioPharma’s Lucid-MS targets the myelin sheath.
• The case for Lucid-MS is grounded in more than a decade of rigorous science.
• Quantum BioPharma's path to phase 2 has been methodical and deliberate.

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A Disease That Steals People’s Movement and Momentum

Multiple sclerosis is a chronic, inflammatory disease of the central nervous system. The immune system turns against the brain and spinal cord, attacking myelin, the protective sheath that surrounds nerve fibers and allows electrical signals to travel efficiently. As myelin degrades, those signals slow, stall or stop entirely. The result is an unpredictable cascade of symptoms, including tingling sensations, vision problems, mobility issues, cognitive impairment, and eventually the progressive loss of physical control.

The disease does not discriminate by age. The average global age of diagnosis is 32, and roughly 1.5% of all MS patients are under 18. Women are diagnosed at twice the rate of men. In the United States alone, nearly one million people are living with MS, a figure that more than doubled from earlier estimates when researchers applied rigorous, modern methodology. And the numbers are growing; prevalence has risen in every world region since 2013.

What makes MS particularly devastating is its progressive nature. For many patients, the disease course is relapsing-remitting at first, meaning symptoms flare and then partially recover. But over time, a significant portion of patients transition into secondary progressive MS, where disability accumulates steadily. The National MS Society reports that many people with MS end up managing multiple medications simultaneously, each targeting different symptoms or relapses, yet none addressing the underlying neurodegeneration eroding their quality of life.

The disease carries a heavy economic burden as well. The global MS therapeutics market was valued at approximately $27.4 billion in 2024 and is forecast to reach $38.62 billion by 2030, driven not by cures but by the sheer number of patients requiring lifelong management. That market reality underscores the scale of the unmet need. Patients need more than management; they need a therapy that can interrupt the disease.

That is precisely what Quantum BioPharma is working to deliver. The company is developing Lucid-MS, a patented, first-in-class drug candidate unlike anything currently approved, which targets the myelin sheath itself, with the goal of preventing, stopping and even possibly allowing for reversing its degradation.

A Different Approach: Protecting the Myelin Sheath Directly

Most approved MS therapies work by modulating the immune system. They suppress or redirect the immune response that attacks myelin, which can reduce relapse rates and slow disability accumulation. These treatments have been meaningful advances. But they do not directly address myelin itself or the tissue being destroyed. They do not rebuild what is lost. And for patients with progressive MS, immune modulation alone is often insufficient.

Lucid-MS takes a different path entirely. Technically known as Lucid-21-302, the drug candidate is a patented New Chemical Entity (NCE), a first-in-class, non-immunomodulatory, neuroprotective compound. Rather than targeting the immune system, Lucid-MS targets the myelin sheath directly. In preclinical models, it has demonstrated the ability to prevent and even reverse myelin degradation, the underlying mechanism of multiple sclerosis. This is a distinction without parallel among currently approved treatments.

A key feature of Lucid-MS is that it does not suppress the immune system. That characteristic sets it apart from most existing therapies and may represent a meaningful safety advantage. It also positions Lucid-MS not as a replacement for immune-modulating treatments but as a potential complement, or if future trials bear out its promise, a foundational therapy in its own right. Additionally, the drug is being developed for oral administration, which would make it far more convenient for patients than many injectable or infusion-based alternatives.

Quantum BioPharma holds exclusive worldwide rights to Lucid-MS through its wholly owned subsidiary, Lucid Psycheceuticals Inc. The company's pipeline is led by a world-class scientific team including advisor Dr. Lakshmi P. Kotra, a recipient of the Julia Levy Award, a senior scientist at the University Health Network, and a professor of medicinal chemistry at the University of Toronto. The scientific leadership also includes Dr. Andrzej Chruscinski, vice president of Scientific and Clinical Affairs, whose background spans Stanford-trained internal medicine, cardiology and neurological research. This team is pursuing a goal that no approved drug has yet achieved: giving MS patients a therapy that directly protects their myelin.

From the Lab to Human Trials: A Decade-Plus of Evidence

The case for Lucid-MS is grounded in more than a decade of rigorous science. The compound has been studied for more than a decade, with results that have been published in some of the most prestigious journals in medicine, including the “Journal of Medicinal Chemistry” and the “Proceedings of the National Academy of Sciences (PNAS).” These peer-reviewed publications document the compound's demonstrated ability to prevent demyelination and promote remyelination in preclinical models.

The animal data is striking. In experiments conducted across multiple laboratories over several years, Lucid-MS accelerated functional recovery in mouse models of MS, preserved myelin and reduced zonal degradation. Documented cases showed mice regaining their ability to walk after treatment. These were not isolated findings but the product of a large cohort of studies. The results were compelling enough to support advancing the compound into human testing.

In 2023, Quantum BioPharma submitted its phase 1 clinical trial application for Lucid-MS for a first-in-human safety and tolerability investigation. The trial included both Single Ascending Dose (“SAD”) and Multiple Ascending Dose (“MAD”) phases, conducted in healthy volunteers. The resulting clinical study report revealed no safety or tolerability issues with daily dosing. Phase 1 dosing in healthy human volunteers was completed successfully, with Lucid-MS described as demonstrating a favorable safety profile and being well tolerated.

If future phase 2 trials in MS patients confirm the preclinical findings — that Lucid-MS can halt or possibly reverse myelin degradation — it would mark a historic first. No currently approved therapy has demonstrated the ability to help MS patients regain physical function that was lost to myelin damage. While human trials are necessary to establish whether the preclinical promise translates to people, the accumulated evidence from a decade of studies provides a scientifically grounded foundation for that hope.

Regulatory Milestones: Filing the IND, Building for Phase 2

Quantum BioPharma's path to phase 2 has been methodical and deliberate. The company has not just pursued the fastest route forward; rather, it has carefully and deliberately assembled the clinical, manufacturing and regulatory infrastructure needed to run a rigorous trial. That discipline is now yielding results.

In late 2025, the company completed dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302. These are critical components of the Investigational New Drug (“IND”) application required by the U.S. Food and Drug Administration (“FDA”) to authorize a phase 2 clinical trial. The completion of these long-duration safety studies represented a significant step toward regulatory submission.

The company also signed agreements with a leading contract development and manufacturing organization (“CDMO”) to develop and manufacture an oral formulation of Lucid-MS, a key step in preparing the drug for clinical use. Then, in April 2026, Quantum BioPharma formally submitted its IND application to the FDA for Lucid-MS, targeting a phase 2 trial evaluating the therapy's efficacy, safety and tolerability in people with MS.

To execute the planned phase 2 trial, Quantum BioPharma signed a binding letter of intent with Allucent, a global contract research organization with deep experience in central nervous system clinical trials. The company also appointed a principal investigator for the planned trial, further advancing the clinical development program. These moves reflect a company that has moved systematically from preclinical promise to regulatory readiness, and is now positioned to generate the human clinical data the MS world has been waiting for.

Groundbreaking Collaboration Illuminates the Path Ahead

Even as Quantum BioPharma advances its phase 2 plans, the company is simultaneously working with a tool that may prove essential to measuring Lucid-MS's impact: a cutting-edge imaging technique to directly visualize myelin in the living human brain. Earlier this year, Quantum BioPharma entered into a joint clinical study with scientists at Massachusetts General Hospital (“MGH”) to validate a novel positron emission tomography (“PET”) imaging technique for monitoring myelin integrity and demyelination in MS.

The study is built around a PET tracer called [¹⁸F]3F4AP, developed by Dr. Pedro Brugarolas, an investigator in the Department of Radiology at MGH and an assistant professor at Harvard Medical School. In addition, Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and an associate professor of neurology at Harvard Medical School, is serving as co-investigator.

The first MS patient was successfully scanned in June 2025, marking the launch of active patient enrollment. In addition, the MGH team published highly promising results in the European Journal of Nuclear Medicine and Molecular Imaging, a study funded by the National Institutes of Health. The tracer demonstrated excellent properties for imaging the human brain and, critically, was able to detect differences across lesions not visible by conventional MRI. By May of this year, the study had reached the important halfway point in patient enrollment, with encouraging preliminary imaging results showing strong signals in acute MS lesions.

The significance of this imaging work for Lucid-MS's development cannot be overstated. One of the core challenges in developing a remyelinating therapy is measuring whether it is actually working, and conventional MRI does not offer a direct, quantitative view of myelin. The [¹⁸F]3F4AP tracer, if validated, could provide exactly that: a real-time biological window into how well a drug is protecting or restoring the myelin sheath. Chruscinski has described its potential to “fundamentally change how we assess demyelination — providing a direct window into axonal health and enabling us to more clearly demonstrate the impact of therapies like Lucid-MS.” This collaboration with University Health Network, Massachusetts General Hospital and Harvard Medical School-affiliated researchers represents a convergence of world-class scientific talent around a shared goal.

Quantum BioPharma is pursuing that goal with urgency and rigor. With a global MS therapeutic market projected to exceed $38 billion by 2030, the commercial stakes are significant. However, for the nearly three million people living with MS worldwide, what matters most is whether a therapy can finally do what none has done before: Stop the disease, repair the damage and give patients back the control of their bodies that MS has taken from them. If Lucid-MS delivers on its preclinical promise in human trials, it will not just be a new drug — it will be a turning point.

Innovation Accelerates Across Neurology, Immunology and Precision Medicine

Recent developments across the biotechnology and pharmaceutical sectors highlight continued progress in the development of therapies, diagnostics and treatment strategies for complex neurological, autoimmune and immune-mediated diseases. Companies are advancing programs through important regulatory approvals, diagnostic milestones, strategic acquisitions and late-stage development activities, reflecting a broader industry focus on precision medicine and targeted approaches to patient care.

Sanofi (NASDAQ: SNY) announced that its Sarclisa subcutaneous formulation has been approved in Japan for patients with multiple myeloma (“MM”). According to the company, Japan’s Ministry of Health, Labour and Welfare in Japan granted approval for the formulation in combination with approved standard-of-care regimens for the treatment of MM. The approval was based on multiple studies, including the pivotal IRAKLIA phase 3 study, which demonstrated noninferior efficacy and pharmacokinetics compared to Sarclisa IV. Japan’s approval follows the first global approval for Sarclisa SC, following the European Union.

Roche Holding AG (OTCQX: RHHBY) announced that its VENTANA(R) PTEN (SP218) RxDx Assay is the first immunohistochemistry companion diagnostic test to receive FDA approval for determining PTEN protein loss in tumors of patients with prostate adenocarcinoma. These patients may now be eligible for treatment with AstraZeneca’s targeted therapy TRUQAP(R) (capivasertib). The new test fulfils an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with TRUQAP.

Biogen Inc. (NASDAQ: BIIB) is expanding its immunology pipeline with its agreement to acquire RayThera Inc. The acquisition adds multiple immunology assets to Biogen’s portfolio, including a lead asset poised to enter phase 1 development. According to the announcement, the companies have entered into a definitive agreement under which Biogen has agreed to acquire RayThera for up to $1 billion, consisting of an upfront payment and, predominantly, payments contingent on the achievement of future clinical and regulatory milestones. RayThera’s portfolio includes multiple anti-inflammatory assets that could potentially treat immune-mediated conditions across a range of indications.

Clene Inc. (NASDAQ: CLNN) reports that after a successful Type C meeting with the FDA, it will file accelerated approval a New Drug Application (“NDA”) for amyotrophic lateral sclerosis (“ALS”). According to the company, minutes from the meeting indicated that the FDA felt that the proposed data may be capable of supporting the submission and review of an NDA under the accelerated approval pathway for CNM-Au8 based on neurofilament light (“NfL”) biomarker data. CNM-Au8 represents a potential first-in-class therapeutic approach for ALS, a disease area with significant unmet medical need. The company expects to submit an NDA for CNM-Au8 to the FDA in the third quarter of 2026.

As scientific understanding of disease biology continues to evolve, companies across the life sciences industry are pursuing new ways to improve diagnosis, expand therapeutic options and address significant unmet medical needs. Collectively, these developments underscore the industry's commitment to delivering more effective, personalized and accessible treatments for patients facing a wide range of serious and chronic conditions.

For more information, visit Quantum BioPharma Ltd.

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