(Adds study details, researcher, physician comment, byline)
By Bill Berkrot
NEW ORLEANS, March 27 AtheroGenics Inc.'s AGIX.O experimental heart drug missed the primary goal of a pivotal late-stage trial, but it cut death, heart attack and stroke and dramatically reduced the risk of patients developing diabetes, researchers said on Tuesday.
The anti-oxidant, anti-inflammatory drug, the first of its kind, reduced the risk of developing diabetes by 64 percent and demonstrated a small but statistically significant reduction in blood sugar after 12 months, researchers said.
Data from the 6,144-patient study were presented at the annual American College of Cardiology scientific meeting here.
The diabetes results may come as a surprise to investors who have abandoned AtheroGenics or who have been betting that the drug, known as AGI-1067, will fail. As of last month, a whopping 51 percent of AtheroGenics' shares had been shorted, according to Nasdaq.
The shares were up 20 percent in early Tuesday trading. They lost nearly two-thirds of their value earlier this month when the company said AGI-1067 had missed its composite primary goal of reducing cardiac death, heart attack, stroke, need for revascularization procedures and unstable angina, or chest pain, by 20 percent.
But when the last two criteria were pulled out, the drug reduced death, heart attack and stroke by a statistically significant advantage over placebo, researchers said.
While those were considered secondary goals, or end points, they are likely to receive attention from heart doctors and investors in the volatile biotechnology stock.
"The death, heart attack and stroke end point is actually more important because those are the worst events," said Dr. Christopher Cannon, a cardiologist at Brigham and Women's Hospital in Boston.
"We probably need some type of confirmatory trial before one could adopt that therapy as an approach, but it certainly keeps it alive as a strategy," he said.
AztraZeneca Plc (AZN.L), seeking to rebuild its depleted developmental drug pipeline, agreed to pay up to $1 billion for exclusive rights to the drug. But the London-based drugmaker can opt out of the deal, and that decision is likely to be based on its interpretation of the results of this study.
Heart patients in the study received either 300 milligrams of AGI-1067 or a placebo on top of a host of standard-of-care medicines they were already taking, such as aspirin, cholesterol-lowering statins, blood thinners and/or diabetes medicines.
As had been seen in earlier trials, the drug had an undesirable impact on blood fats, raising bad LDL cholesterol by about 12 percent and lowering good HDL cholesterol by roughly the same amount. There was also one case of liver failure in a patient who recovered.
But the death and heart attack outcomes and diabetes effect may be enough to keep the drug on track to eventual approval.
"The highest bar in clinical research is to improve the prognosis of patients that are already receiving optimal care," said Dr. Marc Pfeffer, a co-principle investigator of the study.
"Although the formal primary composite end point in (the study) was not met, we believe that the trial generated strong evidence that the use of AGI-1067 will produce tangible clinical benefits for patients with coronary artery disease," he said.
((Reporting by Bill Berkrot; editing by John Wallace; Reuters Messaging: firstname.lastname@example.org phone 646 303-6294))
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