Company Says MD1003 (high dose Biotin) Failed to Help Progressive MS in Phase 3 Trial
March 11, 2020
MedDay Pharmaceuticals announced that its second Phase 3 clinical trial of MD1003®
(high-dose Biotin) in people with progressive MS failed to meet its primary or secondary endpoints. No adverse safety issues were reported.
Read details about the trial on clinical trials.gov
- The trial involved 642 people with primary progressive MS and secondary progressive MS who did not have recent relapses. Participants took MD1003 or placebo three times a day for 15 months.
- The primary endpoint for the study was reversal of functional disability as measured by the proportion of participants with an improvement in either the standard EDSS scale (that largely tests walking ability), or in the time needed to walk 25 feet, at 12 months and confirmed at 15 months.
- Biotin is considered a form of vitamin B, and is a component of enzymes in the body that help break down certain substances in the body. It was being tested to see if it could provide support for what may be increased energy demands of brain cells during the course of MS. Biotin is usually obtained from food.
- The company announced plans to release more detailed results at an upcoming medical meeting.
MD1003 is a registered trademark of MedDay Pharmaceuticals