MedDay Pharmaceuticals announced full enrollment of SPI2, a phase III clinical trial designed to confirm the potential of its investigational drug MD1003 in progressive MS as shown in MS-SPI phase III trial. MedDay is pursuing the clinical development of MD1003 with the objective of filing a New Drug Application (NDA) in the USA and a Marketing Authorization Application (MAA) in Europe in H2 2020.

Enrollment complete in SPI2 phase III study investigating MD1003 in Progressive MS - MedDay has finalized full patient enrollment of its second phase III clinical trial (SPI2) which is aimed at confirming and reinforcing the positive results of the first phase III trial (MS-SPI) that demonstrated the potential of its investigational drug MD1003 to reverse disease progression in progressive MS.

SPI2, a randomized double blind, placebo-controlled trial, is similar in design to the previous phase III study (MS-SPI) using the same endpoint measuring reversal of disease progression, with a larger patient population (n=642) and an extended treatment duration of 15 months minimum. Secondary endpoints include time to EDSS progression, clinical global impression of improvement (CGI and SGI) and mean change in TW25. Exploratory endpoints include brain MRI measures among others. Baseline demographic data recently presented at the ECTRIMS October 2018 Congress confirmed that the study enrolled a population of non-relapsing but progressing patients. In the SPI2 trial, 90 clinical sites are active globally (48 sites in the USA and Canada, 39 in Europe and 3 in Australia). Top-line data of SPI2 study are expected by Q1 2020, with NDA and MAA filing in H2 2020.

Regulatory strategy focused on gaining marketing approval for investigational drug MD1003 in major markets - MedDay interacts continuously with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the development of its investigational drug MD1003 in progressive MS. The company held an in-person EOP2 meeting with FDA in July 2018.

"The mechanism of action of our investigational product MD1003 has significant potential in the treatment of Progressive Multiple Sclerosis," Christian Chavy, Chief Executive Officer of MedDay, said. "MedDay is fully committed to advance its clinical program as initially planned with a view of offering a new therapeutic alternative to patients."