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Idenix Pharmaceuticals, Inc. recently announced that the company has decided to discontinue its clinical development program for IDX184.
IDX184 is a nucleotide polymerase inhibitor in phase IIb development for treating patients suffering from hepatitis C virus (HCV) infection. Idenix also decided not to continue the development of IDX19368, an HCV nucleotide polymerase inhibitor.
We note that Idenix had filed an investigational new drug application (IND) for IDX19368 but had not initiated patient dosing.
We note that in Aug 2012, the US Food and Drug Administration (FDA) put IDX184 on partial clinical hold and IDX19368 on clinical hold due to safety concerns after serious cardiac-related adverse events were found to be associated with
Bristol-Myers Squibb Company’s ( BMY - Analyst Report) BMS-986094 (formerly known as INX-189).
BMS-986094 is also a nucleotide polymerase inhibitor, which was being developed for the treatment of HCV. Bristol-Myers decided to discontinue BMS-986094 due to safety issues.
Subsequently, Idenix submitted the requested cardiac safety data for IDX184 to the FDA in Dec 2012. Idenix has found no evidence of severe cardiac findings till now.
However, the FDA informed Idenix that IDX184 and IDX19368 programs would remain on clinical hold. Hence, the company has decided to discontinue the development of these programs.
Nevertheless, Idenix is completing IND-enabling studies for a uridine nucleotide analog, a sub-class of nucleotide polymerase inhibitors distinct from IDX184, IDX19368 and BMS-986094. Idenix expects to file an IND for this candidate in the first half of 2013.
Idenix is also developing an all-oral direct-acting antiviral (DAA) HCV combination therapy incorporating IDX719, which is a pan-genotypic NS5A inhibitor for HCV. This is being done in collaboration with Janssen Pharmaceuticals, Inc., a US-based arm of Johnson & Johnson's ( JNJ - Analyst Report) global pharmaceuticals segment.
Idenix currently carries a Zacks Rank #2 (Buy). A biopharma stock that currently looks more attractive is Peregrine Pharmaceuticals, Inc. ( PPHM - Snapshot Report) . It carries a Zacks Rank #1 (Strong Buy).