MedDay Pharmaceuticals announced top-line results showing that its experimental drug MD1003, a highly-concentrated pharmaceutical-grade biotin, missed the primary and secondary endpoints of the Phase III SPI2 trial in patients with non-active progressive multiple sclerosis (MS). According to the company, the study 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.
Chief scientific officer Frédéric Sedel stated that the drugmaker will review the latest findings "in detail to understand these outcomes to help inform future clinical research in progressive MS and other neurological diseases." Still, Sedel said he remains "confident of the importance of the neurometabolic approach to neurodegenerative diseases with high unmet medical need."
The randomsied SPI2 trial evaluated three daily doses of MD1003 versus placebo in 642 patients with progressive MS who have not experienced recent relapses. The primary endpoint was reversal of functional disability as measured by the proportion of patients with an improvement in either the Expanded Disability Status Scale (EDSS) or in the time needed to walk 25 feet (TW25) over a 12-month timeframe and confirmed at 15 months.
Secondary goals of the study included relative reduction in the risk of disability progression, global impression of response to treatment evaluated by both the patient and the evaluating physician, and mean change in TW25. MedDay said detailed results of the SPI2 trial will be presented at the American Academy of Neurology (AAN) annual meeting on April 29.
According to the company, the neurometabolic modulator is designed to target both neurodegenerative and demyelination processes through a non-immunological mechanism.
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