MedDay Pharmaceuticals has announced new top-line data showing that its experimental drug MD1003 missed the primary and secondary endpoints of the Phase III SPI2 trial.
The trial, which was evaluating the drug in patients with non-active progressive multiple sclerosis (MS), was designed to confirm positive results of the Phase III MS-SPI trial, which was initially reported in 2015 and also assessed the ability of MD1003 to reverse disease progression in progressive MS.
The company says that further, more detailed results will be presented at the American Academy of Neurology (AAN) meeting in Toronto, April 2020.
The main measure of the study was an improvement in disability, which could be either a lower EDSS score or a reduction in the time to walk 25 feet. However, there was ultimately no improvement in either of these measures in comparison to the placebo group.
Chief scientific officer Frédéric Sedel confirmed that MedDay will review the latest findings "in detail to understand these outcomes to help inform future clinical research in progressive MS and other neurological diseases." Despite the outcome, he commented that the company is still ”confident of the importance of the neurometabolic approach to neurodegenerative diseases with high unmet medical need."
According to the company, the neurometabolic modulator is designed to target both neurodegenerative and demyelination processes through a non-immunological mechanism.
