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Pipeline Drug: MD1003

August 19, 2015


A biotechnology company called MedDay, which focuses on treatment for nervous system disorders, has reported positive data on a drug called “MD1003”. MD1003 is a highly-concentrated pharmaceutical grade biotin and a trial was done using patients with progressive multiple sclerosis. The data showed an improvement of Clinical Global Impression of Change/Improvement (CGI-I), after the patients were being treated for 12 months.

The Clinical Global Impression of Change is a 7 point scale, allowing the clinician to assess the patient’s illness. The range goes from 1 (condition has very much improved) down to 7(condition has very much worsened). During this trial both the clinician and patient assessed their change after one year of treatment. The intervention group’s scores showed significantly better improvement, compared to the placebo group. The primary endpoint was defined as improvement on EDSS (Expanded Disability Status Scale) or timed 25 foot walk.

Commenting on these new results, Prof. Ayman Tourbah, Principal Investigator in the study, CHU de Reims, Neurology, France, said: "Results on CGI and SGI confirm the clinical meaningfulness of the primary and secondary endpoints based on walking assessment. The fact that both CGI and SGI improved very significantly in the active arm compared to the placebo adds consistency to the results."

Frederic Sedel, Chief Executive Officer of MedDay, added: "We are pleased to announce further positive findings which confirm the promising MD1003 Phase 3 data announced earlier this year at AAN. MD1003 remains the only drug to date that has demonstrated an ability to decrease the rate of disease progression and improve a significant proportion of patients with progressive MS.

"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 we look forward to announcing data from this trial later this year and potentially investigating a drug filing thereafter."


Source MedDay Pharmaceuticals, news-medical.net


Pipeline Drug: MD1003 - Wed August 19, 2015 3:54 PM