Boston, MA 09/15/2014 (wallstreetpr) – Global biotech company, Biogen Idec Inc (NASDAQ:BIIB) and research-based pharmaceutical company AbbVie Inc (NYSE:ABBV) disclosed that their Phase three DECIDE clinical study has exhibited a vast improvement in reducing disease activity in people affected by relapsing-remitting multiple sclerosis or RRMS.
Phase III Results
The companies revealed that the drug candidate, ZINBRYTA, dosed once a month has indicated key measures of improvement compared to AVONEX such as new brain lesion development, and reducing annualized relapse pace, according to a statement from Biogen. The results would help the companies to understand ZINBRYTA better as a probable option for treatment of people affected by relapsing-remitting MS.
Both the companies indicated that the phase three results were presented before the Sixth Triennial Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis and the Americas Committee for Treatment in Multiple Sclerosis in Boston.
Efficacy Results
Biogen Idec Inc (NASDAQ:BIIB) and AbbVie Inc (NYSE:ABBV) said that DECIDE was a stage three two-three randomized, double-blind global study to examine whether ZINBRYTA would be able to offer a superior outcome for some of the clinical endpoints in comparison with AVONEX. More than 1,800 patients were enrolled for the study with RRMS.
At the primary point, ZINBRYTA patients exhibited a significant 45% reduction in annualized relapse pace compared to AVONEX. In the secondary endpoints, it showed a much better or superior improvement of 54% reduction compared to AVONEX on the issue of reduction of the number of fresh or newly enlarging T2-hyperintense lesions at the end of the 96th week. Similarly, 73% of the patients have demonstrated relapse-free rate versus 59% of AVONEX patients at the end of the 96th week.
Safety Results
The Biogen Idec Inc (NASDAQ:BIIB) and AbbVie Inc (NYSE:ABBV) disclosed that the stage three results on the safety of ZINBRYTA during the DECIDE trial was in consistent with the stage two trial. There was an increased rate of serious infections of 4% in patients treated with ZINBRYTA compared to 2% of AVONEX. The types and pattern of infections were similar to that observed in the MS population.
Both the companies have indicated that they would file for marketing applications for ZINBRYTA with the regulators in the first half of the next year.
