Idenix Pharmaceuticals (IDIX) Posts Q1 Loss of 24c/Share

Idenix Pharmaceuticals (NASDAQ: IDIX) reported Q1 EPS of ($0.24), $0.05 worse than the analyst estimate of ($0.19).

HCV Pipeline Review

• In April 2014, Idenix reported positive seven-day proof-of-concept data from a phase I/II clinical trial for IDX21437, the Company's lead uridine-based nucleotide prodrug candidate. The trial demonstrated that IDX21437 was well tolerated and exhibited potent pan-genotypic activity with mean maximal viral load reductions of 4.2 - 4.3 log10 IU/mL for treatment-naïve genotype 1, 2 and 3 HCV-infected patients in the highest dose group (300 mg) for seven days. Based on these findings, the 300 mg dose of IDX21437 has been chosen for an anticipated phase II combination study of IDX21437 with samatasvir, Idenix's pan-genotypic NS5A inhibitor. This phase II study is expected to initiate mid-2014.
• Further, under a collaboration with Janssen Pharmaceuticals, Inc., Idenix is evaluating samatasvir, simeprevir and TMC647055/r in a phase II clinical program. HELIX-1 recently reported safety and sustained virologic response rate (SVR4) findings at a medical meeting, and HELIX-2 is expected to report SVR4 data in the second half of 2014. In this phase II program, samatasvir-containing regimens have been administered to more than 140 patients for 12-week treatment durations and have been safe and well tolerated to date.
• Additionally, in April 2014, Idenix initiated enrollment for the healthy volunteer portion of a phase I clinical trial of IDX21459, a follow-on, uridine-based nucleotide prodrug candidate, in Europe. IDX21459 has shown a favorable preclinical profile including potent, pan-genotypic activity and favorable safety with respect to cardiac, mitochondrial and genotoxicity assessments.

For earnings history and earnings-related data on Idenix Pharmaceuticals (IDIX) click here.

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