Synthon Announces Successful Outcomes from Phase III Study of Synthon’s Glatiramer Acetate

04-May-2015 - Netherlands

Synthon announces that data from the open-label extension of the Phase III GATE study of the Company’s generic glatiramer acetate in patients with relapsing remitting multiple sclerosis (RRMS) demonstrate that efficacy, safety and tolerability were maintained over the entire two-year study period. The data further support the safety of switching from Copaxone® to Synthon’s glatiramer acetate.

Following the nine month double-blinded period of the GATE study, in which 796 patients were treated with Synthon’s generic glatiramer acetate (GTR), Copaxone® or placebo, patients initially treated with Synthon GTR continued their treatment for an additional 15 months to complete the planned two-year study period.

Patients from the Copaxone® and placebo groups were successfully switched over to treatment with Synthon GTR for a 15-month period. Results from this part of the study confirmed continued efficacy, measured by MRI parameters and clinical relapses, as well as the continued safety and tolerability during a two-year treatment period with Synthon GTR.

The data further support the safety of switching active therapy from Copaxone® to Synthon’s generic glatiramer acetate. Efficacy, safety and tolerability profiles remained unaffected throughout the duration of the extension study.

Synthon announced results from the GATE study in March 2014 demonstrating that Synthon’s glatiramer acetate had an efficacy and safety profile that was equivalent to Copaxone®. The open-label data will provide further support for the evaluation of Synthon’s glatiramer acetate by regulatory authorities, prescribing neurologists and payers.

https://www.bionity.com/en/news/152667/synthon-announces-successful-outcomes-from-phase-iii-study-of-synthons-glatiramer-acetate.html