Quantum BioPharma Signs Agreement with CDMO for Lucid-MS Oral Drug Formulation

Quantum BioPharma has signed an agreement with a leading CDMO to manufacture an oral drug formulation of Lucid-MS, a potential treatment for multiple sclerosis. The oral formulation will be used in the Company's Phase 2 clinical trial, which aims to test the efficacy of Lucid-MS in humans. Animal models have shown that Lucid-MS can help regain mobility in those with MS.

Title: Quantum BioPharma Advances MS Drug Lucid-MS to Phase 2 with Oral Formulation

Quantum BioPharma Ltd. (NASDAQ: QNTM) has taken a significant step forward in its quest to develop a new treatment for multiple sclerosis (MS) by signing an agreement with a leading contract development and manufacturing organization (CDMO) to manufacture an oral drug formulation of Lucid-MS. This oral formulation will be used in the company's upcoming Phase 2 clinical trial, which aims to test the efficacy of Lucid-MS in humans.

Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound designed to prevent demyelination, a characteristic feature of MS. The drug has shown promising results in animal models over the past decade, demonstrating potential in helping subjects regain walking ability [1]. The oral formulation development represents a crucial step as the company prepares its Investigational New Drug (IND) application with the FDA.

The agreement with the CDMO will enable Quantum BioPharma to develop and manufacture the oral formulation of Lucid-MS, which will serve as the drug product for the Phase 2 clinical trial. The trial will test the efficacy of Lucid-MS as a possible treatment for people to gain back mobility lost with MS. Dr. Andrzej Chruscinski, Vice-President of Scientific and Clinical Affairs at Quantum BioPharma, stated, "We are pleased to announce that we have signed this agreement with a leading CDMO to develop and manufacture an oral formulation of Lucid-MS. This marks an important step in the clinical development of Lucid-MS as we prepare the IND application with the FDA and prepare for our upcoming Phase 2 trial of Lucid-21-302 in MS" [1].

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. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. ("Lucid"), Quantum BioPharma is focused on the research and development of its lead compound, Lucid-MS [2].

Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Unlike other therapies, Lucid-MS won't suppress the immune system, which can increase the risk of infections. The company is now preparing an application seeking regulatory clearance in the U.S. for a Phase 2 clinical study in MS patients, with an expected submission to the FDA by the end of this year [3].

The development of Lucid-MS is a promising step in the fight against MS, a condition that affects over 2 million people worldwide. The oral formulation of Lucid-MS, if proven effective, could provide a new treatment option for patients with MS, potentially offering a breakthrough in managing the disease.

References:
[1] https://finance.yahoo.com/news/quantum-biopharma-signs-agreement-manufacture-114000297.html
[2] https://multiplesclerosisnewstoday.com/news-posts/2025/08/08/daily-doses-lucid-ms-found-safe-healthy-adults-new-study/
[3] https://www.stocktitan.net/news/QNTM/quantum-bio-pharma-signs-agreement-to-manufacture-oral-drug-9segd9rip6hg.html