Glenmark Pharmaceuticals, a research-driven, global, integrated pharmaceutical company focused on finding a treatment for multiple sclerosis, has announced the enrollment of the first patient in their multicenter clinical trial for Genzyme’s investigational infusion therapy vatelizumab in patients suffering from relapsing remitting multiple sclerosis (RRMS). The EMPIRE trial, which is already in its phase II of development, aims to evaluate the efficacy of the therapy compared to placebo, as well as its safety, tolerability, and pharmacokinetics.
Vatelizumab is a humanized monoclonal antibody designed to target VLA-2, which is a collagen-binding integrin explicit on activated lymphocytes. The therapy aims to reduce the burden of the chronic inflammatory demyelinating and neurodegenerative disease, that starts on the central nervous system and causes inflammation and damages. In addition, inflammatory damages and demyelinating lesions are often related to neurodegeneration in MS patients.
The mechanism of action of vatelizumab, which is developed in a collaboration between Glenmark Pharmaceuticals and Genzyme, is not yet fully understood. However, the researchers believe that it will be able to block VLA-2 on activated immune cells, which may enable the interference with collagen-binding in areas of inflammation, as well as leading to the reduction of inflammatory cascade associated with MS.
“We are excited about the commencement of this trial and are pleased with the continued progress of our partnership with Sanofi/Genzyme,” said the President of Biologics and Chief Scientific Officer of Glenmark Pharmaceuticals Ltd., Michael Buschle. EMPIRE, which will be conducted for 12 weeks, is a global phase 2a/2b double-blind, randomized, placebo-controlled study that will study the efficacy, safety, and dose-response of vatelizumab in 168 patients with active RRMS at55 sites in ten different countries.
In addition, Genzyme is also conducting an MS R&D pipeline, designed to develop treatments for unmet needs related to relapsing and progressive forms of MS, in which the company is focusing mainly on selective immunomodulation, neuroprotection and remyelination. The company’s most prominent research is related to molecules in various stages of clinical development, including the discovery of new molecules with application in the fields of inflammation, pain management and oncology.