Biopharmaceutical company Idenix Pharmaceuticals, Inc. (IDIX) said Monday it is discontinuing its clinical development program for two Hepatitis C Virus or HCV drug candidates, IDX184 and IDX19368, amid adverse cardiac events seen in a competitor's mid-stage clinical trials of a similar family of compounds.
Cambridge, Massachusetts-based Idenix engages in the discovery and development of drugs for the treatment of human viral diseases in the U.S. and Europe, and its primary research and development focuses on the treatment of patients with HCV.
The U.S. Food and Drug Administration or FDA, had in August 2012 placed IDX184 on partial clinical hold and IDX19368 on clinical hold after serious cardiac-related adverse events were reported for HCV patients treated with HCV drug candidate BMS-986094, a nucleotide polymerase inhibitor previously under development by Bristol-Myers Squibb Co. (BMY).
Bristol-Myers acquired BMS-986094 drug candidate when it completed its $2.5 billion acquisition of Inhibitex, Inc. in February 2012. Bristol-Myers also discontinued the development of BMS-986094, formerly known as INX-189, in August 2012.
IDX184 is a nucleotide polymerase inhibitor in phase IIb testing for the treatment of HCV infection, while IDX19368 is an HCV nucleotide polymerase inhibitor. Idenix had previously filed an investigational new drug application, but had not initiated patient dosing for the treatments.
All three drug candidates are 2'-methyl guanosine nucleotide prodrugs, including Bristol-Myers' drug candidate BMS-986094.
Meanwhile, Idenix had in December 2012 completed the submission of requested cardiac safety data for IDX184 to the FDA. However, the FDA reaffirmed its clinical hold on Idenix's two drug candidates.
"We are completing IND-enabling studies for a uridine nucleotide analog, which is in a sub-class of nucleotide polymerase inhibitors distinct from IDX184, IDX19368 and BMS-986094. We anticipate filing an IND for this next-generation compound during the first half of 2013, and we also plan to continue to advance other preclinical nucleotide prodrugs in earlier-stage development," President and CEO Ron Renaud said in a statement.
In late July, the FDA had granted Fast Track designation for IDX719 for chronic hepatitis C infection or HCV treatment, being co-developed by Janssen Pharmaceuticals Inc. IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent proof-of-concept clinical trial in genotypes 1-4, treatment-naive HCV patients.
As per the FDA Modernization Act of 1997, Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening condition and that shows the potential to address an unmet medical need for such a condition. The Fast Track program enables a company to file a New Drug Application on a rolling basis.
According to the US National Institutes of Health, hepatitis C virus that can cause liver damage, affects about 180 million people worldwide and about 1.5 percent of the U.S. population, killing at least 10,000 Americans each year. Currently, there is no vaccine for hepatitis C available, with the current treatment drugs being given through injection.
IDIX closed Monday's regular trading session at $4.73, down $0.13 or 2.67% on a volume of 0.99 million shares. The stock lost a further $0.33 or 6.98% in after-hours trading.
by RTT Staff Writer
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