Experimental Medications: Monoclonal Antibody Medications
Company: Glenmark Pharmaceuticals and Sanofi Genzyme
- Administered via intravenous infusion
- Vatelizumab is being studied in RRMS
Vatelizumab is a humanized monoclonal antibody that targets VLA-2, a collagen-binding integrin expressed on activated lymphocytes (immune-system cells produced to fight infection and disease). This is similar to the mechanism of action of Tysabri, although with a different molecular target. The precise mechanism of action of vatelizumab in MS is not known, although it is hypothesized to block VLA-2 on activated immune cells, preventing the penetration of inflammatory lymphocytes from crossing into the brain, thus potentially reducing inflammatory events in MS.
The EMPIRE study,16 initiated in 2014, is a global Phase IIa/IIb 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 for the MRI portion and two years for the safety follow-up. It is expected to enroll 168 patients at 55 sites in 10 countries.
Although no clinical data had been made public, Sanofi announced in a press release in fall 2015 that a pre-planned interim analysis revealed the primary efficacy endpoint was not met. The principal developer of this agent, Glenmark, planned to continue the EMPIRE study, which is expected to be completed in mid-2016.