Safety Concerns Halt Trial for Abbott Kidney Treatment

Abbott Laboratories (ABT) said Thursday a clinical trial of a once-promising experimental treatment for kidney disease was discontinued due to safety concerns including an excess death rate among the drug’s users.

The setback clouds the prospects for the drug, bardoxolone, which Abbott and analysts had expected to generate more than $1 billion in annual sales if it reached the market. The drug was viewed as one of the keys to help Abbott’s planned pharmaceutical spinoff, AbbVie, be successful as a stand-alone company.

Abbott shares, which had recently hit multi-year highs, tumbled $3.90, or 5.6%, to $65.14 in recent trading.

Abbott was informed of the trial’s discontinuation Wednesday by its partner for the drug, Reata Pharmaceuticals Inc., Abbott said in a filing with the Securities and Exchange Commission. Reata confirmed the news in a separate statement.

Spokesmen for the companies declined further comment.

In 2010, Abbott paid $450 million up-front–with potential for additional milestone payments and royalties–to Reata to license certain non-U.S. rights for bardoxolone and to obtain a minority equity investment in Reata. Reata holds U.S. rights while Abbott obtained rights outside the U.S. excluding Asia.

Last year, Abbott executives described bardoxolone as having the potential to “dramatically change” the treatment for chronic kidney disease, with a potential market launch in 2014.

Reata discontinued a late-stage, or Phase 3, study titled “Beacon,” evaluating bardoxolone in patients with advanced chronic kidney disease and type 2 diabetes.

The trial was started in June 2011 and estimated enrollment was about 2,000 patients, according to clinicaltrials.gov. The study was targeted to be completed in June 2013. Some patients were receiving placebo daily and others received bardoxolone.

The study was designed to test whether bardoxolone was better than placebo in delaying the need for chronic dialysis, kidney transplant or cardiovascular death.

The discontinuation was based on a recommendation by the study’s independent data monitoring committee, due to “excess serious adverse events and mortality in the bardoxolone methyl arm,” the companies said.

Abbott said regulatory agencies have been notified, and study sites and study participants are being informed.

The companies will review the data to determine whether there is an appropriate path forward for development of the drug in chronic kidney disease or other potential uses.

A prior study had shown generally positive results for bardoxolone. In a phase 2 study, patients receiving bardoxolone had significant increases in a measure of kidney function known as estimated glomerular filtration rate, or GFR, compared with a placebo, according to results published last year in the New England Journal of Medicine.

Bardoxolone users in that study did, however, experience certain adverse events at higher rates than those on placebo. These included muscle spasms and hypomagnesemia , or low levels of magnesium in the blood. Hypomagnesemia can be a life-threatening emergency, according to the U.S. National Library of Medicine, though it can be treated.

The Beacon trial required patients enrolling to have blood magnesium levels above a certain threshold.

Abbott and Reata didn’t provide further details about the nature of the adverse events in the Beacon trial.

-Jon Kamp contributed to this article.

Write to Peter Loftus at peter.loftus@dowjones.com

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Copyright © 2012 Dow Jones Newswires

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