MedDay Pharmaceuticals has announced that the second pivotal Phase III trial (SPI2) of its investigational product MD1003 has not met its primary and secondary endpoints. 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). 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.
We are clearly disappointed that SPI2 did not meet its primary and secondary endpoints. Going forward, we will continue to evaluate the trial data and confer with regulators. We would like to thank our collaborators including the participating clinicians, medical staff and, most importantly, the patients for all of their efforts and participation in the trial. All were invaluable partners throughout the process of completing the SPI2 trial.
Catherine Moukheibir, Chief Executive Officer of MedDay Pharmaceuticals
“We will review the findings in detail to understand these outcomes to help inform future clinical research in progressive MS and other neurological diseases,” commented Frédéric Sedel, MD, PhD, Chief Scientific Officer and co-Founder of MedDay Pharmaceuticals. “I remain confident of the importance of the neurometabolic approach to neurodegenerative diseases with high unmet medical need.”
The randomised, 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. Additional exploratory endpoints incorporated in this trial included brain MRI measures, quality of life measures and measurements of ambulation using a Fitbit® device.
For more information on the trial design, please visit: https://clinicaltrials.gov