An experimental drug from Abbott Laboratories (ABT) and Reata Pharmaceuticals Inc. reversed the decline of kidney function in diabetics in a study that doctors say may lead to a new way of treating chronic kidney disease.
The trial of 227 patients found that Abbott and Reata’s drug bardoxolone methyl boosted kidney performance by about 30 percent over a year, said David Warnock, a nephrologist at the University of Alabama at Birmingham and senior researcher on the study published today in the New England Journal of Medicine. No existing drug produces such improvement, he said.
Twenty-six million Americans suffer from chronic kidney disease and about 500,000 are on dialysis, Warnock said. Blood pressure drugs such as ace inhibitors and angiotensin receptor blockers, the standard treatment now, slow the progression of the disease. If proven effective in a bigger trial, bardoxolone may become the first in a new class of medicines that preserve kidney function and delay the need for dialysis by reducing inflammation in the kidney, he said in a telephone interview.
“We don’t have anything to offer these patients today that will change the course of the disease,” said Warnock, who is a consultant for closely held Reata, based in Irving, Texas. “Here we have a drug that may change the whole ballgame.”
Chronic kidney disease associated with diabetes is the leading cause of renal failure, according to the study.
In the trial, also being presented today at the European Renal Association-European Dialysis and Transplant Association Congress in Prague, kidney patients already on blood pressure medicines got either bardoxolone or placebo for a year. Patients on bardoxolone had rapid improvements in kidney-filtering ability that were sustained for a year, the study showed. Patients who got placebo didn’t improve. Side effects of bardoxolone included muscle spasms.
The results were from the second of three stages of testing generally required for U.S. Food and Drug Administration approval. This month, Abbott and Reata said they began a 1,600- patient, final-stage study that will assess whether bardoxolone keeps diabetic kidney patients alive and off dialysis. Results are due in 2013.
The treatment has the potential to be a “multibillion dollar drug globally,” said Phillip Nalbone, an analyst at Wedbush Securities.
“This is the first thing in a very, very long time that has looked promising” for chronic kidney disease, he said in a telephone interview.
Abbott, based in Abbott Park, Illinois, paid Reata $450 million last September to acquire most rights to the drug outside the United States. Tokyo-based drugmaker Kyowa Hakko Kirin Co. holds rights in many Asian markets.
Abbott became interested in bardoxolone after seeing a poster of Reata’s early trial results several years ago at a scientific meeting, said James Stolzenbach, an Abbott vice president.
“We spent some time talking to Reata, and the more we investigated it, the more interested we got,” he said. Bardoxolone “is very unique.”
Reata originally licensed the drug from Dartmouth College in Hanover, New Hampshire, and the University of Texas M.D. Anderson Cancer Center in Houston as a treatment for cancer, not kidney disease, said Warren Huff, Reata’s chief executive officer, in a telephone interview.
When Reata researchers conducted a trial in advanced cancer patients, “we kept noticing that the renal function improved in all these patients,” he said in a telephone interview. “It was somewhat serendipitous.”
That led Reata to start studying the medicine in kidney patients, Huff said.
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