MedDay, a biotechnology company focused on the treatment of nervous system disorders, reports additional positive data from its pivotal Phase III clinical trial, MS-SPI, with MD1003, a highly-concentrated pharmaceutical grade biotin, in patients with Progressive Multiple Sclerosis. The data, to be announced on Saturday 20th June at The 1st Congress of the European Academy of Neurology (EAN), shows an improvement of the Clinical Global Impression of change observed after 12 months of treatment with MD1003 and confirms the positive results presented at the American Academy of Neurology in April 2015.
The Clinical Global Impression of change is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. 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 (p<0.0001 and p=0.0094, respectively).
These important 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 (p=0.0051). The mean change of EDSS between M0 and M12 decreased in the MD1003 group (-0.03) compared to progression in the placebo group (+0.13, p=0.014). In the MD1003 arm, only 4% of patients treated with MD1003 exhibited EDSS progression at M9 confirmed at M12 vs 13% in the placebo group (p=0.07), which equates to a 67% decreased risk of progression in the active arm within the studied period.
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."