AbbVie, Biogen Announce Publication of ZINBRYTA Phase 3 Data

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The FINANCIAL — Full results from the Phase 3 DECIDE study published this week in the New England Journal of Medicine (NEJM), as well as new post-hoc analyses of Phase 3 clinical data presented at an international congress, show once-monthly, investigational ZINBRYTA (daclizumab high-yield process [HYP]) improved results on key measures of multiple sclerosis (MS) disease activity in patients with relapsing-remitting MS (RRMS) compared to interferon beta-1a 30 mcg intramuscular (IM) injection.

In the new post-hoc analyses, ZINBRYTA was shown to increase the percentage of patients achieving no evidence of clinical and MRI disease activity, improve cognitive processing speed and reduce 24-week confirmed disability progression across a broad range of subgroups at two years compared to interferon beta-1a IM. Lead investigators on behalf of Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) presented these new findings today at the 31st Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in Barcelona, Spain (7-10 October), according to Biogen.

“The new DECIDE data presented at ECTRIMS provide further insight into the potential of daclizumab HYP to reduce MS disease activity, including the efficacy it has demonstrated in reducing MS relapse rates, disability progression and brain lesion development,” said Ludwig Kappos, M.D., chair, Department of Neurology and head, MS-Research Group, University Hospital, Basel, Switzerland, and lead investigator for DECIDE. “Over the two years of data we analyzed, nearly twice as many patients treated with daclizumab HYP had no evidence of MS disease activity compared to those taking an approved MS treatment.”

Efficacy Compared to Interferon Beta-1a IM

New post-hoc analyses of data from DECIDE presented at ECTRIMS assessed multiple measures of MS disease activity and showed that compared to interferon beta-1a IM over two years (p values are nominal):

More ZINBRYTA-treated patients exhibited no evidence of disease activity (NEDA) (24.6% versus 14.2%; p<0.0001; n=1,841). These results were based on a greater number of ZINBRYTA patients achieving both clinical NEDA (no relapses and no disability progression) and MRI NEDA (no new/newly enlarging T2-hyperintense lesions and no gadolinium-enhanced lesions).

ZINBRYTA-treated patients showed improvement in cognitive processing speed and prevention of clinically meaningful cognitive decline, as measured by greater mean improvements from baseline on the Symbol Digit Modalities Test (SDMT; +4.08 [12.4] versus +2.89 [12.7]; p=0.0274). Higher percentages of ZINBRYTA patients had a ≥3-point (60.0% versus 54.1%; p=0.0153) or ≥4-point (55.4% versus 50.1%; p=0.0366) improvement in SDMT scores at week 96 (n=1,402).

ZINBRYTA treatment resulted in reductions in the risk of 24-week confirmed disability progression across a wide range of pre-specified patient subgroups based on baseline characteristics.

“These new analyses advance our understanding of ZINBRYTA and its ability to slow the progression of MS compared to a widely used, approved therapy,” said Gilmore O’Neill, M.D., vice president of Multiple Sclerosis Research and Development at Biogen. “In addition, we are encouraged by the positive results of the analyses of ZINBRYTA on measures of cognitive function, which is also at risk as MS progresses.”

The full results from the pivotal Phase 3 DECIDE study were published in the 8 October 2015 issue of the NEJM. The DECIDE trial enrolled more than 1,800 patients with RRMS in 28 countries.

“There is still significant unmet medical need for patients with relapsing-remitting multiple sclerosis. We are encouraged by these results and the potential ZINBRYTA may have for people living with MS,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.


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