Additional results from Phase III trial of MD 1003 (biotin) support benefits in multiple sclerosis-MedDay

MedDay reports additional positive data from its pivotal Phase III clinical trial, MS-SPI, with MD 1003 (biotin) in patients with progressive Multiple Sclerosis. The data shows an improvement of the Clinical Global Impression of change observed after 12 months of treatment with MD 1003 and confirms the positive results presented at the American Academy of Neurology in April 2015. During the MS-SPI trial, the Clinical Global Impression of change has been assessed by the clinician (clinician global impression, CGI) as well as by the patient (subject global impression, SGI) after 12 months of treatment. Mean CGI and SGI scores assessed at month 12 were statistically significantly better in the intervention group compared with the placebo group.

These results confirm the previously reported data of MS-SPI where the primary endpoint was defined as the proportion of patients who improved either on EDSS or on timed 25-foot walk (TW25) at M9, with a confirmation of the improvement at 12 months (M12) was met. The mean change of EDSS between M0 and M12 decreased in the MD 1003 group (-0.03) compared to progression in the placebo group (+0.13). In the MD 1003 arm, only 4% of patients treated with MD 1003 exhibited EDSS progression at M9 confirmed at M12 vs 13% in the placebo group, which equates to a 67% decreased risk of progression in the active arm within the studied period. Data will be presented at The 1st Congress of the European Academy of Neurology.

Comment: A second Phase III placebo-controlled trial is underway looking at the effect of MD1003 in MS patients with permanent visual loss following optic neuritis and MedDay plans to announcing data from this trial later this year, potentially investigating a drug filing thereafter.