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Pipeline Drug MD1003 is Showing Efficacy in Treating Inactive but Progressive MS

April 27, 2016

MedDay recently disclosed full study results from the MS-SPI and MS-ON Phase 2b/3 trials of its drug product MD1003 in patients with multiple sclerosis (MS). Specifically, the trials included people with “not active” progressive MS and those with either relapsing or progressive MS or visual loss, respectively.

The MS-SPI trial, focusing on not-active progressive MS, a difficult-to-treat form of the disease, explored the effects of MD1003 in 103 patients, compared to 51 others who received placebo during 12 months. The study continued in a 12-month extension phase, during which all patients received the drug but remained uninformed of whether they had been treated with MD1003 in the first phase.

MS-SPI met its primary endpoint — the proportion of patients who improved on either the Expanded Disability Status Scale (EDSS) or a timed walk test. MedDay reported improvement in 12.6 percent of patients after nine months, confirmed at 12 months, and equivalent to a reversed progression. During the same period, none of the placebo-treated patients improved. During the extension phase, patients who had been on MD1003 from the start continued improving, with 13.2 percent of them demonstrating less disability at 18 months, and 15.4 percent at 24 months.

“Full results of the MS-SPI study are especially remarkable. This is the first time that a drug has reversed the progression of the disease in a statistically significant proportion of patients,” Professor Ayman Tourbah at CHU de Reims, France, and the studies’ principal investigator, said in a press release. “In addition, if we look at the mean Expanded Disability Scale (EDSS) change, the data compare very favorably with all previous trials that looked at the same endpoint. Almost no progression was observed in patients treated with MD1003 for 24 months, and this has never been observed before.”

The studies also demonstrated good safety and tolerability data for MD1003.