IDX184 Phase IIb Study Design
IDX184 Phase IIb Interim Study Results
The first 31 patients have completed 28 days of treatment, and the interim data have shown that IDX184 was well-tolerated and that there were no serious adverse events associated with therapy. The side effect profile was consistent with that seen with PegIFN/RBV. The independent DSMB has reviewed the data for the first 31 patients and has recommended continuing enrollment of the study. The Company has submitted the interim data, along with the DSMB's recommendations, to the
RVR findings demonstrated that 73% of patients in the 100 mg IDX184 arm (n=15) and 63% in the 50 mg arm (n=16) had undetectable virus (LLOQ < 25 IU/ml) at 28 days. Currently 87% of patients in the 100 mg arm and 94% in the 50 mg arm had undetectable virus at a median of 8 weeks of treatment. There have been no virologic breakthroughs observed in the study to date.
"These interim results are encouraging as they confirm the antiviral activity and safety of IDX184 in combination with pegylated interferon and ribavirin,"
IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. IDX184 is currently being developed under a partial clinical hold.
CONFERENCE CALL AND WEBCAST INFORMATION
Idenix will hold a conference call today at
A replay of the conference call and webcast will be available until
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 or any other drug candidate; the successful development of novel combinations of direct-acting antivirals for the treatment of hepatitis C; the likelihood and success of any future clinical trials involving our drug candidates; and expectations with respect to funding of operations and future cash balances. 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; the Company's dependence on its collaboration with
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.
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