Phase 3 clinical trial results from Biogen Idec and AbbVie presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRMIS) suggest that relapsing-remitting multiple sclerosis patients experience symptom relief when given monthly subcutaneous injections of ZINBRYTA (daclizumab high-yield process). Patients saw a statistically significant reduction in disease activity when compared to patients treated with the established treatment, AVONEX (interferon beta-1a).
“The full results from DECIDE demonstrate that ZINBRYTA significantly improved key measures of multiple sclerosis disease activity compared to AVONEX, including reducing annualized relapse rate and new brain lesion development,” said Ludwig Kappos, MD, lead investigator of the DECIDE trial, in a news release from Biogen Idec. “These results help us better understand ZINBRYTA as a potential treatment option for people with relapsing-remitting MS.”
This positive data was generated through the two- to three-year, phase 3 study of more than 1,800 relapse-remitting multiple sclerosis patients from 28 countries. Patients were given either 150 mg subcutaneous ZINBRYTA every four weeks or 30 mcg intramuscular AVONEX once weekly.
Upon compiling and analyzing the results, the research team found a statistically significant 45% reduction in annualized relapse rate in patients treated with ZINBRYTA — 73% of patients were relapse-free, while only 59% of those on AVONEX were relapse-free. These patients also had fewer enlarging brain lesions and a better performance on the Expanded Disability Status Scale.
“For people living with multiple sclerosis, there continues to be a need for new medicines that work in different ways,” stated Gilmore O’Neill, vice present of Multiple Sclerosis Research and Development at Biogen Idec. “If approved, ZINBRYTA would offer a novel mechanism to treating multiple sclerosis, in a self-administered, once-monthly dosing regimen.”
Three presentations were given at the conference, and all gave further details of the safety and efficacy of ZINBRYTA in relapse-remitting multiple sclerosis patients. Biogen Idec and AbbVie have their sights on future development. According to Michael Severino, MD, executive vice president of Research and Development and Chief Scientific Officer of Abbvie, “The results from DECIDE further support the potential of ZINBRYTA and we look forward to submitting the data for this investigational therapy to regulatory agencies.”