Phase III trial of MD 1003 meets primary endpoint in Multiple Sclerosis-MedDay

MedDay has announced positive results from the pivotal Phase III clinical trial, MS-SPI demonstrating the efficacy and safety of MD 1003 (biotin) in the treatment of primary and secondary progressive multiple sclerosis. The primary endpoint was met (p=0.0051, Fisher�s exact test) in the intent to treat population with 12.6% of patients in the MD 1003 arm showing an improvement of EDSS (Expanded Disability Status Scale) or TW25 (a timed 25-foot walk) at Month 9, confirmed at Month 12, compared to none of the patients in the placebo arm. The primary endpoint was supported by secondary analyses showing evidence for a decrease in the risk of disease progression.

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. The study was not prospectively powered to reach significance for this secondary endpoint.

MD 1003 was well tolerated. The overall incidence of adverse events was similar across the two groups. One patient died from suicide in the active arm, however this event was not considered as related to the drug. In 5 patients, abnormal laboratory data indicated that MD 1003 may affect the results of immunoassays which use biotinylated antibodies and substrates. A second Phase III placebo-controlled trial is underway looking at the effect of MD 1003 in MS patients with permanent visual loss following optic neuritis. Results from this trial are expected later this year. The data were presented at the American Academy of Neurology Annual Meeting.