Biopharmaceutical company Mapi Pharma will present two-year clinical data from its Phase II study of Glatiramer Acetate Depot for the treatment of relapsing remitting multiple sclerosis (RRMS) at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which will take place on October 10-12 in Berlin, Germany.
Glatiramer Acetate Depot consists of extended-release microspheres containing glatiramer acetate, intended for administration once every 28 days and has a linear release profile over that time period.
In the extension study, all participants received a 40mg dose of Glatiramer Acetate Depot once every four weeks. The number of adverse events was considerably reduced during the second year of treatment compared with the first year. No immediate post-injection reactions, as are frequently seen with Copaxone and generic glatiramer acetate, were detected. Efficacy results showed there was no significant change in mean Expanded Disability Status Scale (EDSS) score at two years compared with baseline in the per protocol population (PPP). No Magnetic resonance imaging (MRI) disease activity was noted in any patients during that period. Eighty-one point eight percent (81.8%) of PPP patients achieved No Evidence of Disease Activity (NEDA) at two years.
Dr. Shlomo Flechter, Head of The MS Clinical Research and Therapy Unit at Assaf Harofeh Medical Center and the Coordinating Primary Investigator of the study extension commented: “These results suggest that Glatiramer Acetate Depot is safe, well tolerated and efficacious. The high proportion of patients in the per protocol population that achieved NEDA (84.6% and 81.8%, at one and two years, respectively) is particularly encouraging. If these results are confirmed in the placebo-controlled Phase III study, Glatiramer Acetate Depot has the potential to establish a new standard of care for MS drugs.”
Source MS-UK 10/10/2018