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MedDay reports positive pivotal Phase III study results with MD1003 in patients with Progressive Multiple Sclerosis
First time a drug has decreased the rate of disease progression in addition to improving a significant proportion of patients with progressive MS
Primary endpoint met (p = 0.0051)
Mean EDSS change improved at 12 Months (p = 0.015)
MD1003 was well tolerated
Data presented for the first time at the American Academy of Neurology Annual Meeting today and webcast to take place on Tuesday 28th April at 1200 EST / 1700 CEST
April 24, 2015 12:00 PM Eastern Daylight Time
PARIS, France--(BUSINESS WIRE)--MedDay, a biotechnology company focused on the treatment of nervous system disorders, today announced positive results from the pivotal Phase III clinical trial, MS-SPI. The study demonstrated evidence of the efficacy and safety of MD1003, a highly-concentrated pharmaceutical-grade biotin administered at a dose of 300 mg per day in the treatment of primary and secondary progressive multiple sclerosis, a major area of unmet medical need.
“This is the first time that a drug has been able to decrease the rate of disease progression in addition to improving a significant proportion of patients with progressive MS.”
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 MD1003 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 (0%) 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 MD1003 group (-0.03) compared to progression in the placebo group (+0.13, p=0.015). 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. The study was not prospectively powered to reach significance for this secondary endpoint.
MD1003 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 MD1003 may affect the results of immunoassays which use biotinylated antibodies and substrates.
Prof. Ayman Tourbah, Principal Investigator of the study, CHU de Reims, Neurology, France, said: "We are encouraged by the outcomes of this pioneering and stringently designed MS-SPI trial. The fact that no patient in the placebo group met the primary endpoint indicates that the study bar was designed to be very high. The rapid rate of recruitment into this multi-centre study illustrates the serious need for a well-tolerated drug by patients with primary and secondary progressive multiple sclerosis. The significant proportion of patients showing improvement at twelve months, coupled with the decrease in risk of disease progression demonstrated here, makes MD1003 a potentially important new therapy for patients and clinicians in the field of MS.”
Commenting on the results of the study, Frederic Sedel, Chief Executive Officer of MedDay, said: “This is the first time that a drug has been able to decrease the rate of disease progression in addition to improving a significant proportion of patients with progressive MS.
“We look forward to the analyses of other secondary endpoints and MRI studies which might provide additional data about the mechanism of action. Furthermore, 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. Results from this trial are expected later this year and based on previous discussions with regulators we intend to investigate a drug filing thereafter.”
http://www.businesswire.com/news/hom...y#.VTp4Mf6RAjg
MedDay reports positive pivotal Phase III study results with MD1003 in patients with Progressive Multiple Sclerosis
First time a drug has decreased the rate of disease progression in addition to improving a significant proportion of patients with progressive MS
Primary endpoint met (p = 0.0051)
Mean EDSS change improved at 12 Months (p = 0.015)
MD1003 was well tolerated
Data presented for the first time at the American Academy of Neurology Annual Meeting today and webcast to take place on Tuesday 28th April at 1200 EST / 1700 CEST
April 24, 2015 12:00 PM Eastern Daylight Time
PARIS, France--(BUSINESS WIRE)--MedDay, a biotechnology company focused on the treatment of nervous system disorders, today announced positive results from the pivotal Phase III clinical trial, MS-SPI. The study demonstrated evidence of the efficacy and safety of MD1003, a highly-concentrated pharmaceutical-grade biotin administered at a dose of 300 mg per day in the treatment of primary and secondary progressive multiple sclerosis, a major area of unmet medical need.
“This is the first time that a drug has been able to decrease the rate of disease progression in addition to improving a significant proportion of patients with progressive MS.”
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 MD1003 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 (0%) 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 MD1003 group (-0.03) compared to progression in the placebo group (+0.13, p=0.015). 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. The study was not prospectively powered to reach significance for this secondary endpoint.
MD1003 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 MD1003 may affect the results of immunoassays which use biotinylated antibodies and substrates.
Prof. Ayman Tourbah, Principal Investigator of the study, CHU de Reims, Neurology, France, said: "We are encouraged by the outcomes of this pioneering and stringently designed MS-SPI trial. The fact that no patient in the placebo group met the primary endpoint indicates that the study bar was designed to be very high. The rapid rate of recruitment into this multi-centre study illustrates the serious need for a well-tolerated drug by patients with primary and secondary progressive multiple sclerosis. The significant proportion of patients showing improvement at twelve months, coupled with the decrease in risk of disease progression demonstrated here, makes MD1003 a potentially important new therapy for patients and clinicians in the field of MS.”
Commenting on the results of the study, Frederic Sedel, Chief Executive Officer of MedDay, said: “This is the first time that a drug has been able to decrease the rate of disease progression in addition to improving a significant proportion of patients with progressive MS.
“We look forward to the analyses of other secondary endpoints and MRI studies which might provide additional data about the mechanism of action. Furthermore, 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. Results from this trial are expected later this year and based on previous discussions with regulators we intend to investigate a drug filing thereafter.”
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