Biogen Reports Positive Results From Phase3 Study Of Peginterferon Beta-1a In MS

By RTT News, January 24, 2013, 07:57:00 AM EDT

(RTTNews.com) - Biogen Idec Inc. ( BIIB ) on Thursday released the primary efficacy analysis and safety data from its Phase 3 pivotal clinical trial, ADVANCE. The company said results support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting multiple sclerosis or RRMS.

Peginterferon beta-1a is 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 primary endpoint of ADVANCE, annualized relapse rate or ARR at one year, was met for both the two-week and four-week dose regimens.

Results showed that peginterferon beta-1a also met the secondary endpoints of risk of 12-week confirmed disability progression, proportion of patients who relapsed and magnetic resonance imaging or MRI assessments for both dose regimens.

The company noted that Adverse events or AEs, serious adverse events or SAEs and discontinuations due to AEs were similar across both dose groups. Overall with both dose regimens studied, the risk-benefit profile of peginterferon beta-1a appears to be favorable.

The ADVANCE study included more than 1,500 patients with RRMS and was designed to evaluate the efficacy, safety and tolerability of peginterferon beta-1a compared to placebo at one year.

Results showed that when administered via subcutaneous (SC) injection, peginterferon beta-1a 125 mcg demonstrated a significant reduction in ARR at one year. Compared to placebo, ARR reduction with two-week dosing was 35.6 percent (p<0.001) and with four-week dosing was 27.5 percent (p<0.02).

Results showed that peginterferon beta-1a also met all secondary endpoints compared to placebo for both dose regimens.

In Advance, both dosing regimens showed favorable safety and tolerability profiles. The overall incidence of SAEs and AEs was similar among the peginterferon beta-1a and placebo groups. The most common SAE was infections, which was balanced across all treatment groups (1 percent per group).

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Biogen Reports Positive Results From Phase3 Study Of Peginterferon Beta-1a In MS