Abbott Laboratories, said Friday that a new phase 2 study of bardoxolone methyl showed improvement in kidney function in patients with moderate-to-severe chronic kidney disease and type 2 diabetes.
Eugene Sun, Vice President, Global Pharmaceutical Research and Development Abbott said, "These results set the stage for our Phase 3 program for bardoxolone methyl, which will evaluate whether it is possible to delay or prevent progression to dialysis."
Bardoxolone methyl is a novel, first-in-class antioxidant inflammation modulator. In January 2010, Reata and Kyowa Hakko Kirin (KHK) announced a licensing agreement providing KHK with the exclusive rights to develop and commercialize bardoxolone in Japan and other selected Asian markets. In September 2010, Reata formed a strategic partnership with Abbott for the development and commercialization of bardoxolone in other ex-U.S. markets.
The Phase 2 dose-finding trial, the BEAM study, showed patients with moderate-to-severe chronic kidney disease and type 2 diabetes, eGFR at 52 weeks significantly improved with bardoxolone methyl treatment of 75 mg.
The double-blind, placebo-controlled trial involved 227 patients, randomly assigned to receive placebo, 25 mg, 75 mg or 150 mg of bardoxolone methyl orally, once daily for 52 weeks.
The most common adverse event associated with the bardoxolone methyl-treated group was muscle spasm, transient elevations in liver enzymes, nausea, decreased appetite and hypomagnesemia.
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