IDX719 three-day proof-of-concept study
The three-day proof-of-concept study evaluated IDX719 in 64 treatment-naïve, genotype 1, 2, 3 or 4 HCV-infected patients. Genotype 1 patients were randomized to receive placebo, 25 mg QD (once-daily), 50 mg QD, 50 mg BID (twice-daily) or 100 mg QD for three days. Genotype 2, 3 or 4 patients were randomized to receive placebo, 50 mg BID or 100 mg QD for three days.
No patients experienced a rebound ( > 1.0 log10 IU/mL increase over the lowest viral load) during the treatment period and maximum viral load reductions were typically achieved within 24-72 hours post dose. There were no safety-related discontinuations or serious adverse events. IDX719 was safe and well tolerated at daily doses up to 100 mg for three days. Idenix intends to initiate a phase II clinical trial evaluating IDX719 in combination therapy in 2013.
"To our knowledge, these are the most advanced clinical results validating the robust, pan-genotypic activity of an NS5A inhibitor in HCV," commented
IDX184 phase IIb combination study
A randomized, double-blind phase IIb clinical trial is evaluating IDX184 in 67 treatment-naive genotype 1 HCV-infected patients. The study features two treatment arms, either 50 mg or 100 mg of IDX184 administered once-daily for 12 weeks, each arm in combination with PegIFN/RBV. Response-guided therapy is used to complete an additional 12 or 36 weeks of PegIFN/RBV treatment.
All patients had completed treatment with IDX184 when in
Similar numbers of patients achieved a complete early virologic response (cEVR; virus levels < 25 IU/mL at 12 weeks) in the 50 mg (26/34; 76%) and in the 100 mg (27/33; 82%) groups. Rates of rapid virologic response (RVR; virus levels < 25 IU/mL at 4 weeks) were also comparable between the 50 mg (18/34; 53%) and the 100 mg (18/33; 55%) groups. The difference in response rates from data previously reported is primarily due to an increased number of genotype 1b patients as well as IL28B CT/TT patients who were enrolled in the second patient cohort. No patient experienced virologic breakthrough during the 12-week IDX184/Peg-IFN/RBV treatment period. The majority of patients are in the ongoing PegIFN/RBV extension treatment phase, and complete sustained virologic response (SVR) results will be available in 2013.
"The IDX184 presentation at AASLD details much of the key clinical data we intend to submit to the
ABOUT HEPATITIS C
Hepatitis C virus is a common blood-borne pathogen infecting three to four million people worldwide annually. The
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX184 and IDX719; and the likelihood and success of any future clinical trials involving IDX184 or IDX719. Actual results may differ
materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates
and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the year ended
All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.
CONTACT: Idenix Pharmaceuticals Contacts:Source:
Kelly Barry(617) 995-9033 (media) Teri Dahlman(617) 995-9807 (investors)
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