Quantum BioPharma Partners with CDMO to Manufacture Oral Formulation of Lucid-MS for MS Treatment Trial

Quantum BioPharma has signed an agreement with a leading CDMO to manufacture an oral drug formulation of Lucid-MS, a potential breakthrough drug for multiple sclerosis. The oral formulation will serve as the drug product for the company's upcoming Phase 2 clinical trial. Lucid-MS has shown promising results in preclinical models, preventing demyelination and promoting mobility in animal models. The agreement marks an important step in the clinical development of Lucid-MS.

Quantum BioPharma (NASDAQ: QNTM) has taken a significant step forward in its quest to develop a breakthrough 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. The oral formulation will serve as the drug product for 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. 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 marks an important milestone in the clinical development of Lucid-MS. The oral formulation will be used in the Phase 2 clinical trial, which will test the efficacy of Lucid-MS in humans. The preclinical results have been encouraging, with animal models demonstrating restoration of walking ability. If these results translate to humans, this could represent a paradigm shift in MS treatment from merely slowing progression to actually reversing disability.

Quantum BioPharma's announcement also highlights the unique mechanism of action of Lucid-MS. Unlike most approved MS treatments, which are immunomodulatory (targeting the immune system's attack on myelin), Lucid-MS is described as non-immunomodulatory and neuroprotective, specifically targeting the demyelination process itself. This approach could potentially address a fundamental aspect of MS pathology rather than just managing immune response.

The progression to Phase 2 trials, bypassing extensive Phase 1 safety studies, suggests the company may be leveraging existing safety data or regulatory pathways. The fact that they are preparing an IND application with the FDA indicates they are still in the pre-approval process for clinical testing in the US.

As a New Chemical Entity (NCE) with patent protection, Lucid-MS would have market exclusivity if approved, potentially offering Quantum significant commercial advantages if clinical trials prove successful.

References:
[1] https://www.stocktitan.net/news/QNTM/quantum-bio-pharma-signs-agreement-to-manufacture-oral-drug-9segd9rip6hg.html