Date: 2016-03-04
Type of information: discontinuation of development
phase: 2
Announcement: discontinuation of development
Company: Genzyme (USA - MA), a Sanofi company
Product: vatelizumab
Action
mechanism: monoclonal antibody. Vatelizumab is a humanized monoclonal antibody that targets VLA-2, (Very Late Antigen 2) integrin receptor, a collagen-binding integrin expressed on activated lymphocytes. The mechanism of action of vatelizumab is not known, although it is hypothesized to block VLA-2 on activated immune cells, leading to interference with collagen-binding in areas of inflammation, and thus may reduce the inflammatory cascade in multiple sclerosis. This monoclonal antibody has been in-licensed from Glenmark Pharmaceuticals .
Disease: relapsing remitting multiple sclerosis (RRMS)
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country:
Trial
details: EMPIRE is a global phase 2a/2b double-blind, randomized, placebo-controlled study assessing the efficacy, safety and dose-response of vatelizumab in patients with active RRMS. The study duration is 12 weeks. The study is expected to enroll 168 patients at 55 sites in 10 countries.
Latest
news: * On March 4, 2016, Sanofi announced, in its annual report, that the vatelizumab project has been discontinued in 2015. A prospectively planned interim analysis completed in October 2015 did not meet the pre-defined primary efficacy endpoint and treatment has been discontinued. No safety concerns prompted this decision. The compound has been discontinued. * On November 4, 2014, Genzyme announced enrollment of the first patient in a multicenter Phase II clinical trial to evaluate its nvestigational infusion therapy vatelizumab in patients with relapsing remitting multiple sclerosis (RRMS). The trial, called EMPIRE, is designed to assess the efficacy of vatelizumab vs. placebo in RRMS patients. The safety, tolerability and pharmacokinetics of vatelizumab will also be assessed.
