By Saabira Chaudhuri
Biogen Idec Inc. (BIIB) said it has seen positive results from the first year of a two-year late-stage study of its investigational candidate for a type of multiple sclerosis.
Biogen said results from its two-year pivotal Phase 3 "Advance" study of Plegridy, its investigational candidate for relapsing-remitting multiple sclerosis dosed once every two weeks or every four weeks, indicate that Plegridy significantly reduced multiple sclerosis disease activity, including relapses, disability progression and brain lesions, compared with placebo at one year.
"These full first-year results provide a more complete picture of Plegridy and its positive effects on the reduction of relapse, disability progression and lesion development," said Peter Calabresi, director at the Johns Hopkins Multiple Sclerosis Center. "These data suggest that, if approved, Plegridy may offer the benefit of a less frequent dosing schedule, which would be a meaningful advance for people living with multiple sclerosis."
Plegridy--also called peginterferon beta-1a--met the primary endpoint of reducing annualized relapse rate at one year by 36% compared with placebo. It also met its secondary endpoint, reducing the proportion of patients who relapsed by 39% compared with placebo. Additionally, it significantly reduced the number of gadolinium-enhancing lesions by 86% compared with placebo.
Biogen described Plegridy as a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less-frequent dosing schedule. The investigational drug candidate is a member of the interferon class of treatments and, if approved, would be a new addition to this class, which often is used as a first-line treatment for multiple sclerosis.
The latest announcement comes after, in January, Biogen said data from a late-stage trial of Plegridy were positive. At the time, Biogen said the study's primary endpoint was met for both the two-week and four-week dose regimens. Results showed that Plegridy also met the secondary endpoints. It noted that with both dose regimens studied the risk-benefit profile of Plegridy appears to be favorable.
Also in January, Biogen reported its fourth-quarter earnings fell 2.7% as the biotechnology company's preparations to launch a new drug for multiple sclerosis increased expenses and masked revenue growth from its existing multiple sclerosis treatment.
Shares closed Tuesday at $175.61 and were inactive in recent premarket trading. The stock has risen 47% in the past 12 months.
Write to Saabira Chaudhuri at [email protected]