Disappointing topline results from high dose biotin study

A large clinical trial evaluating high dose biotin (MD1003, Qizenday) in secondary and primary progressive MS has failed to show that the treatment leads to improvements in disability.

Topline results from the study have been announced in a press release from the manufacturer, MedDay. Detailed results of the study will be presented at the American Academy of Neurology (AAN) meeting in Toronto, April 2020.

About the study

The SPI2 trial evaluated the safety and effectiveness of three daily doses of 100mg of high dose biotin compared to placebo in 642 people with progressive MS without recent relapses, also called non-active progressive MS. The main measure of the study was an improvement in disability, which could be either a lower EDSS score or a reduction in the time to walk 25 feet. There was no improvement in either of these measures in comparison to the placebo group.

About MD1003

MD1003 is a highly concentrated formulation of biotin which has been undergoing clinical studies.

An earlier clinical trial (MS-SPI) which recruited 154 participants with progressive MS had provided initial evidence that high doses of biotin might have an impact on disability and progression. The main measure of the study was improvement in disability after 9 months of treatment which was still evident at 12 months. Improvement in disability could be either a reduction in EDSS or a reduction in the time to walk 25 feet. Slightly less than 13% of the MD1003 group and none of the placebo group met this criteria.

Biotin, also known as vitamin H or coenzyme R, is one of the B-group vitamins (vitamin B7). It is involved in a wide range of cell processes. It has been suggested that very high doses of biotin may be effective in MS by promoting myelin repair through activation of an enzyme involved in myelin synthesis and by enhancing energy production in demyelinated nerves.