Reata Pharmaceuticals has slammed the brakes on a late-stage study of bardoxolone, citing safety concerns related to adverse events and an elevated rate of death seen among patients taking the chronic kidney disease (CKD) drug. The termination of the BEACON study is a major setback for Abbott Laboratories ($ABT), which had invested huge sums in bardoxolone and a second-generation portfolio that had been expected to provide its pharma spinout with blockbuster revenue as it diversified a product line dominated by Humira.
"Clinical trial sites have been notified, and patient participants are being instructed to stop taking study drug and return to the clinic for a final visit," Texas-based Reata announced in a statement. Abbott's shares were down about 5% in midmorning trading following a disappointing quarterly report.
Just two years ago, Abbott agreed to pay $450 million in upfront and near-term milestones just for the ex-U.S. rights to bardoxolone - along with another $350 million in longer term milestones. And late last year, it followed up with a $400 million cash payment to nail rights to the second-gen portfolio, the kind of upfront commitment rarely seen in biopharma these days.
Bardoxolone was originally seen as a promising cancer drug. But in one of its cancer studies, researchers saw a big improvement in renal function among all renal cancer subjects. Arrested progression of CKD or recovered kidney function was a provocative finding, and Reata pushed ahead with two Phase IIa trials for CKD in 2008, which produced positive results.
Cowen, among others, believed the drug had a shot at blockbuster revenue. And Reata CEO Warren Huff didn't hesitate in projecting a multibillion-dollar future for the drug. Reata was named a Fierce 15 company last year. Now the future of its lead program is in peril, and the biotech faces an uncertain future.
- here's the press release
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