Edition:
India

AB Science Announces The Publication Of The Positive Phase 2/3 Clinical Trial With Masitinib


Monday, 8 Jul 2019 

July 8 (Reuters) - AB Science SA ::Reg-AB SCIENCE ANNOUNCES THE PUBLICATION OF THE POSITIVE PHASE 2/3 CLINICAL TRIAL WITH MASITINIB IN ALS IN THE JOURNAL AMYOTROPHIC LATERAL SCLEROSIS AND FRONTOTEMPORAL DEGENERATION.STUDY AB10015 REACHED ITS PRIMARY ENDPOINT AND SHOWED THAT MASITINIB AT 4.5 MG/KG/DAY IN COMBINATION WITH RILUZOLE WAS ABLE TO SIGNIFICANTLY (P-VALUE < 0.05) SLOW ALSFRS-R DECLINE BY 27% AS COMPARED WITH THE ACTIVE RILUZOLE CONTROL AT WEEK 48.KEY SECONDARY ENDPOINT, PFS (A TIME-TO-EVENT ANALYSIS, MEASURING THE EARLIEST EVENT BETWEEN DEATH AND FUNCTIONAL DECLINE OF AT LEAST 9 POINTS IN ALSFRS-R)5, WAS ALSO STATISTICALLY SIGNIFICANT (P<0.05), WITH A CLINICALLY MEANINGFUL 25% DELAY IN PROGRESSION (MEDIAN PFS OF 20.0 MONTHS FOR MASITINIB AS COMPARED TO 16.0 MONTHS FOR CONTROL).OTHER SECONDARY ENDPOINTS WERE ALSO SIGNIFICANT (P<0.05), with a 29% SLOWING OF DETERIORATION IN QUALITY-OFLIFE (ALSAQ-40) AND A 22% SLOWING OF DETERIORATION IN RESPIRATORY FUNCTION (FVC).SAFETY WAS ACCEPTABLE AND CONSISTENT WITH MASITINIB’S KNOWN RISK PROFILE.