Further results of the SPI2 trial will be presented at the upcoming American Academy of Neurology 2020 Annual Meeting in Toronto.
Frédéric Sedel, MD, PhD
MedDay Pharmaceuticals has announced that their second phase 3 trial designed to assess the safety and efficacy of high-dose biotin (MD1003) in progressive multiple sclerosis (MS) failed to meet both its primary and secondary end points.1
“We will review the findings in detail to understand these outcomes to help inform future clinical research in progressive MS and other neurological diseases,” Frédéric Sedel, MD, PhD, chief scientific officer and co-founder of MedDay Pharmaceuticals, said in a statement.1 “I remain confident of the importance of the neurometabolic approach to neurodegenerative diseases with high unmet medical need.”
At the 2017 joint meetings of the European and Americas Committees for Treatment and Research in Multiple Sclerosis in Paris, France, positive data from a phase 2/3 study of MD1003, a neurometobolic modulator, showed improvements on the Expanded Disability Scale Scale (EDSS) and Timed 25-Foot Walk (TF25) test compared with placebo.
In December 2019, the company reported positive results from the phase 3 MS-PSI study (NCT02220933), which demonstrated the drug’s ability to meet the primary end point as well as demonstrate a potential to reverse disease progression in progressive MS over a 12-month period.2
The double-blind, placebo-controlled SPI2 study (NCT02936037) included 642 patients with progressive MS who were randomly assigned to 3 daily doses of either 100mg of MD1003 or placebo.1
Reversal of functional disability, measured by the proportion of patients with an improvement in either the EDSS or in TF25 over 12 months, with further confirmation at 15 months, was used as the primary end point of the study. 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 TF25 were all recorded as secondary end points. Notably, the investigational treatment did not show any treatment-emergent safety signals.1
“We are clearly disappointed that SPI2 did not meet its primary and secondary end points. Going forward, we will continue to evaluate the trial data and confer with regulators,” Catherine Moukheibir, chief executive officer of MedDay Pharmaceuticals, said in a statement.1
The company plans to announce more details from the SPI2 study at the upcoming American Academy of Neurology (AAN) 2020 Annual Meeting in Toronto, Ontario, Canada.
1. MedDay reports top-line data from phase 3 trial “SPI2” for treatment of progressive forms of multiple sclerosis [news release]. Paris, France: MedDay Pharmaceuticals. businesswire.com/news/home/20200310005779/en/MedDay-Reports-Top-Line-Data-Phase-III-Trial. March 10, 2020. Accessed March 10, 2020.
2. MedDay reports last patient study visit in second phase 3 clinical trial with MD1003, an important milestone towards completion of the SPI2 study in progressive multiple sclerosis [news release]. Paris, France: MedDay Pharmaceuticals. medday-pharma.com/2019/12/12/2031/. December 12, 2019. Accessed March 10, 2020.