Idenix Reports Favorable Resistance Profile for IDX719, a Potent, Pan-Genotypic HCV NS5A Inhibitor, at EASL Meeting
CAMBRIDGE, Mass., April 24, 2013 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported detailed resistance data from in vitro studies and from a three-day monotherapy clinical trial of IDX719, the Company's once-daily, potent, pan-genotypic NS5A inhibitor for the treatment of hepatitis C virus (HCV) infection. These data are being presented on Saturday, April 27, in a poster session at the 48th Annual Meeting of the European Association for the Study of the Liver (EASL), which is being held April 24 - 28, 2013 in Amsterdam, The Netherlands.
Data from the three-day proof-of-concept study demonstrated that IDX719 was well-tolerated at daily doses up to 100 mg and showed potent antiviral activity across HCV genotypes 1-4, with mean maximal viral load reductions up to approximately 4.0 log10 IU/mL. These data were supported by earlier in vitro findings. Clinical plasma samples at baseline, at end of treatment and at one week post-treatment were sequenced for mutations in NS5A at known IDX719 resistance-associated locations.
-- The most common treatment-emergent resistant mutations were detected at
NS5A positions 28, 31 and 93. The profile of these mutations varied
-- The only resistance mutation present at baseline found to negatively
affect IDX719 response was M31 in GT2-infected patients. In contrast,
all GT4-infected patients had virus with M31 at baseline and responded
favorably to IDX719 treatment.
-- A GT1b-infected patient with a baseline Y93H mutation, which confers in
vitro resistance to IDX719, achieved a 2.79 log10 IU/mL viral load
reduction after three days of once-daily 25 mg IDX719, indicating that
IDX719 can retain activity against virus with known resistance
The poster presentation is titled, "Treatment-Emergent Variants Following 3 Days of Monotherapy with IDX719, a Potent, Pan-Genotypic NS5A Inhibitor, in Subjects Infected with HCV Genotypes 1-4" (Abstract No. 1209).
"These additional resistance data support the promising profile of
IDX719 as a potent, pan-genotypic component of future HCV combination treatment regimens," commented Douglas Mayers, M.D., Chief Medical Officer of Idenix. "We look forward to evaluating IDX719 as part of all-oral combination therapies through our collaboration with Janssen, beginning with the initiation of a phase II clinical trial of IDX719 and simeprevir in the first half of this year."
IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, IDX719 has been safe and well tolerated after single and multiple doses of up to 100 mg in healthy volunteers (n=36; up to 7 days duration) and HCV-infected patients (n=69; up to 3 days duration). There have been no treatment-emergent serious adverse events reported in the program. IDX719 has demonstrated potent pan-genotypic antiviral activity in HCV-infected patients with mean maximal viral load reductions up to approximately 4.0 log10 IU/mL across HCV genotypes 1-4 in a proof-of-concept, three-day monotherapy study.
ABOUT HEPATITIS C
Hepatitis C virus is a common blood-borne pathogen infecting three to four million people worldwide annually. The World Health Organization
(WHO) estimates that more than 170 million people worldwide are chronically infected with HCV, representing a nearly 5-fold greater prevalence than human immunodeficiency virus.
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases.
Idenix's current focus is on the treatment of patients with HCV. For further information about Idenix, please refer to www.idenix.com.
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. 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 any expressed or implied statements with respect to: the Company's plans to continue to developing nucleotide polymerase inhibitors for HCV; its clinical development plans for its uridine nucleotide analog drug candidate and IDX719; its plans to advance other preclinical nucleotides; and statements regarding the efficacy and safety of its clinical compounds. 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 due to numerous risks inherent in pharmaceutical research and development; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, preclinical and 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; 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 important 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 December 31, 2012, as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.
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 Contact:
Teri Dahlman (617) 218-7987
Posted: April 2013