People with progressive multiple sclerosis are enrolling in a new and global Phase 3 study of MD1003, a high-dose biotin, “about as well as can be expected,” said Frédéric Sedel, co-founder and CEO of MedDay Pharmaceuticals, which is developing the high-dose biotin, a type of vitamin B.
“So far, so good,” Sedel said in an interview Thursday with Multiple Sclerosis News Today at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, which runs through Oct. 28. “We are really on the right curve.”
That trial, called MS-SPI2 (NCT02936037), aims to enroll 600 primary or secondary progressive patients with no inflammatory activity at over 80 sites across the U.S., Canada, and Europe. It is essential to the therapy’s potential approval in the United States, Sedel said, having been specifically requested by the FDA.
But — possibly before SPI2 concludes — MD1003 might be an approved progressive MS treatment in the European Union. Sedel confirmed that MedDay has filed for regulatory approval with the European Medicines Agency (EMA) and the company is in discussions with regulatory agencies there.
He anticipates a favorable decision, noting “we strongly believe that we have enough data collected so far for EU approval.”
This data was primarily collected in a smaller-scale, but “similar,” Phase 3 trial of MD1003 (NCT02220933) in non-inflammatory progressive patients called MS-SPI. And, he said, it comes from “real-life” results collected on thousands of people in France who have been using MD1003 under an early access program.
Some 6,500 progressive patients have taken high-dose biotin — of the same quality and at the same dose given in the clinical studies — under this program, giving MedDay access to “a kind of registry … real, live data.”
Information collected largely regards safety, and results are “reassuring,” Sedel said. Simple efficacy points are also being gathered and largely support efficacy data recorded in official trials.
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