Phase III SPI2 trial of MD 1003 fails to meet endpoints in multiple sclerosis.- MedDay Pharma

MedDay Pharmaceuticals announced that the second pivotal Phase III trial (SPI2) of its investigational product MD 1003 (biotin) has not met its primary and secondary endpoints in progressive multiple sclerosis (MS). There were no treatment emergent safety signals. SPI2 was designed to confirm the results of the first positive Phase III study, MS-SPI, in progressive multiple sclerosis (MS). The randomized, double-blind, and placebo controlled SPI2 trial evaluated safety and efficacy of three daily doses of 100mg of MD1003 versus placebo in 642 patients with progressive MS without recent relapses, also called not-active progressive MS. The primary endpoint for the study 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 time frame and confirmed at 15 months. Secondary endpoints included the relative reduction in the risk of disability progression; global impression of response to treatment evaluated independently by both the patient and the evaluating physician; and mean change in TW25. Detailed results of the SPI2 trial will be presented to the medical community at the upcoming American Academy of Neurology (AAN) 2020 Annual Meeting on April 29th in Toronto, Canada.