Glenmark Pharma said it will continue to develop the Phase II MS candidate vatelizumab (GBR 500)—whose development rights Sanofi has returned to the Indian drug developer following disappointing clinical results.

Sanofi’s action ends a collaboration launched in 2011 that gave Glenmark $50 million upfront and could have generated an additional $613 million for the company. The deal was Glenmark’s first for an original drug, and furthest along in its pipeline of proprietary treatments.

In a single sentence tucked into its press release announcing third quarter results yesterday, Sanofi said it was “following the results of a Phase II pre-planned interim analysis in Multiple Sclerosis that revealed the primary efficacy endpoint was not met.” The statement gave no further details.

Glenmark issued its own statement confirming Sanofi’s action and noting that the pharma giant’s decision was not due to safety concerns, adding: “Glenmark will continue to pursue the relicensing of GBR 500 after it’s returned from Sanofi.”

Vatelizumab is a humanized monoclonal antibody that targets VLA-2, a collagen-binding integrin expressed on activated lymphocytes.

The mechanism of action of vatelizumab is not known. The drug candidate is believed 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 MS, reasoned Glenmark and Genzyme, a Sanofi company.

The first patient was enrolled last November in EMPIRE, a global Phase IIa/IIb double-blind, randomized, placebo-controlled study assessing the efficacy, safety and dose-response of vatelizumab in patients with active relapsing remitting multiple sclerosis (RRMS).

EMPIRE’s primary objectives were efficacy compared to placebo, as measured by a reduction in new contrast-enhancing lesions (CELs) in RRMS patients, and response to multiple doses of vatelizumab.

The trial’s secondary objectives were evaluating the safety and tolerability of vatelizumab compared to placebo, and evaluating the compound’s pharmacokinetics. The study was expected to enroll 168 patients at 55 sites in 10 countries, Glenmark said in a November 4, 2014, statement.

As of September 25, the trial was recruiting patients, the latest update posted on the EMPIRE trial’s page on ClinicalTrials.gov by Genzyme.








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