May 15, 2020
High-dose biotin (MD1003) failed to reverse functional disability in people with progressive forms of multiple sclerosis in phase 3 trial
MedDay Pharmaceuticals conducted a phase 3 clinical trial to evaluate the safety and efficacy of an investigational MS treatment, high-dose biotin (MD1003®) in people with progressive MS. The trial involved 642 people with primary progressive MS and secondary progressive MS who did not have recent relapses.
In March 2020, the company released top-line data from their phase 3 clinical trial, reporting that the MD1003 product did not meet its primary and secondary endpoints. The primary endpoint for the trial was reversal of functional disability as measured by the proportion of patients with either an improvement in Expanded Disability Status Scale (EDSS) or time needed to walk 25 feet (TW25) over 12 and 15 months. The trial did not report any significant adverse events for those taking MD1003. This larger phase III trial, SP12 was anticipated to confirm the previously reported positive results from its first phase III study (MS-SPI).
MD1003 is a highly concentrated formulation of biotin (vitamin H). D-biotin is a Health Canada-licensed natural health product which, at concentrations of 100 – 300 mg/day in the MD1003 formulation, is ~10,000 times higher than the recommended daily intake as a food supplement.
Refer to the MedDay Pharmaceuticals press release for more information.
For details about the trial refer to clinical trials.gov