Genzyme Launches Phase 2 Vatelizumab Trial In RRMS

Sanofi company Genzyme announced that it has kicked off the Phase 2 clinical trial of its investigational infusion therapy vatelizumab in patients with relapsing remitting multiple sclerosis (RRMS).

Vatelizumab is a humanized monoclonal antibody (mAb) that targets VLA-2, a collagen-binding integrin found on activated lymphocytes. It is believed that vatelizumab blocks VLA2 on activated immune cells, in turn reducing inflammation. The company is developing vatelizumab with Glenmark Pharmaceuticals, which outlicensed the drug to Sanofi in 2011 for all indications.

The placebo controlled, double blind, randomized, Phase 2A/2B EMPIRE trial will evaluate the efficacy of vatelizumab against placebo in patients with RRMS. The drug’s safety, pharmacokinetics, and tolerability will also be investigated. Genzyme said it expects to enroll 168 patients across 55 sites in 10 countries for the trial, which will last 12 weeks.

David Meeker, President and CEO of Genzyme, “We are pleased to commence patient enrollment for our vatelizumab trial in relapsing MS. This milestone… aligns with our pipeline strategy to focus on areas of unmet need.”

Multiple sclerosis is a chronic inflammatory neurodegenerative and demyelinating disease of the central nervous system (CNS). Excessive inflammation with the central nervous system results in inflammatory damage associated with demyelinating lesions experienced by patients with multiple sclerosis.

“Continuous inflammation and neurodegeneration from the onset of multiple sclerosis can lead to significant disability. The EMPIRE trial should enable us to assess vatelizumab’s ability to impact the acute inflammatory components of MS and evaluate its potential as an effective MS treatment,” said Dr. Eva Havrdova, MS Center, Department of Neurology of First Medical Faculty at Charles University in Prague.

Earlier this year, Genzyme presented its multiple sclerosis pipeline, including vatelizumab, at the 30th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) held in Boston this September.