Quantum BioPharma has gone ahead and signed an agreement with a leading CDMO to manufacture oral Lucid-MS Drug formulation, which is a potential breakthrough drug in the case of multiple sclerosis.
Apparently, the oral formulation is going to serve as the drug product for the upcoming phase 2 clinical trial of the company. Lucid-MS has shown promising results when it comes to preclinical models, safeguarding demyelination, and also promoting mobility within animal models. The agreement goes on to mark a very significant step when it comes to clinical development of Lucid-MS.
It is well to be noted that Quantum BioPharma has gone on to take a very prominent step forward when it comes to its quest to develop a breakthrough treatment in terms of multiple sclerosis (MS) by signing an agreement with one of the leading contract development and manufacturing organizations in order to manufacture oral Lucid-MS Drug formulation. The oral formulation is going to serve as a drug product for the upcoming phase 2 clinical trial of the company that looks forward to testing the efficacy of Lucid-MS in humans.
Notably, Lucid-MS happens to be a first-in-class, non-immunomodulatory, neuroprotective compound, which is designed to safeguard demyelination, which is a characteristic feature of MS. The drug has gone on to show promising results when it comes to animal models over the past decade, thereby demonstrating its potential in terms of helping subjects regain their ability to walk. The oral formulation development happens to represent a very critical step since the company prepares its investigational new drug—IND application within the FDA.
The fact is that this agreement with the CDMO happens to mark a very significant milestone within the clinical development of Lucid-MS. The oral formulation, which is going to be used in the phase 2 clinical trial, will test the Lucid-MS efficacy in humans. The preclinical results have been very promising, with animal models showing restoration of walking capacity. If these results go on to translate to humans, it could very well represent a major shift in MS treatment from just slowing the progression to actually reversing the disability.
The announcement made by Quantum BioPharma also underscores the distinct mechanism of action of Lucid-MS. Unlike most of the MS treatments that are approved, which, by the way, happen to be immunomodulatory, which means they target the immune systems attack on myelin, Lucid-MS is described as a non-immunomodulatory as well as neuroprotective option, which specifically targets the demyelination process itself. This kind of approach can potentially address the basic aspect of MS pathology and not just manage the immune response.
The progression when It comes to phase 2 trials, Bypassing the extensive phase 1 safety studies goes on to suggest that the company may be making utmost use of the existing safety data or regulatory pathways. The fact that they are now preparing an IND application along with the FDA indicates that they are still in the pre-approval process when it comes to clinical testing in the US.
As a new chemical entity (NCE), along with patent protection, Lucid-MS will indeed have market exclusivity if it gets approved by potentially offering Quantum certain prominent commercial benefits if the clinical trials prove to be successful.
