Idenix Pharmaceuticals Announces Completion of Proof-of-Concept Study for IDX899 in Treatment-Naive HIV-Infected Patients
September 04 2008 - 8:00AM
PR Newswire (US)
- 100 mg cohort demonstrates potent antiviral activity and
favorable safety profile - CAMBRIDGE, Mass., Sept. 4
/PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc.
(NASDAQ:IDIX), a biopharmaceutical company engaged in the discovery
and development of drugs for the treatment of human viral and other
infectious diseases, today announced that it has completed the
proof-of-concept study evaluating IDX899, a non-nucleoside reverse
transcriptase inhibitor (NNRTI) being developed for the treatment
of HIV-1. Data from the study demonstrate that the 100 mg/day
cohort achieved a mean plasma viral load reduction of 1.87 log10
after seven days of treatment, similar to the potency observed with
the other evaluated doses of 800 mg, 400 mg and 200 mg/day in this
study. As with the other cohorts, no treatment-related serious
adverse events were reported for any of the patients receiving 100
mg/day of IDX899 and no patients discontinued the study. "We are
pleased that HIV-1-infected patients receiving IDX899 in this trial
achieved potent viral suppression at all doses tested," said
Douglas Mayers, M.D., Idenix's chief medical officer. "With the
promising antiviral activity and safety profile seen to date,
especially at low doses, we believe that IDX899 could become an
important part of combination antiretroviral therapy." The phase
I/II clinical trial was designed to evaluate the safety,
tolerability, antiviral activity and pharmacokinetics of IDX899.
Four cohorts of 800 mg/day, 400 mg/day, 200 mg/day and 100 mg/day
were completed with ten HIV-1-infected treatment-naive patients
randomized 8:2 in each cohort to receive oral once-daily IDX899 or
matching placebo, respectively, for seven days. Patients (n=32)
receiving once-daily oral administration of 800 mg, 400 mg, 200 mg
and 100 mg of IDX899 achieved mean viral load reductions of 1.78,
1.78, 1.84 and 1.87 log10, respectively, after seven days of
treatment as tested with the Roche Amplicor(R) 1.5 assay. Patients
(n=8) receiving placebo achieved a mean plasma viral load increase
of 0.10 log10. As with IDX899-treated patients in the 800 mg, 400
mg and 200 mg cohorts, all patients receiving 100 mg/day of IDX899
showed a consistent response with all patients exhibiting a one log
or greater (range: 1.3 - 2.4 log10) reduction in viral load after
seven days of treatment. No treatment-related serious or
non-serious adverse events were reported and no patients
discontinued the study. The most common adverse events observed
were dyspepsia, headache and nausea; the rate of these events was
similar between IDX899-treated patients and those receiving
placebo. Additionally, no patterns in laboratory abnormalities
between treatment groups were observed during the treatment period.
Two additional studies were also completed that evaluated the
potential for a pharmacokinetic drug-drug interaction between
IDX899 and other drugs for the treatment of HIV-1, as well as the
safety and tolerability of IDX899 when administered in combination
with those drugs. These separate studies were conducted using
Reyataz(R) and Truvada(R) in combination with IDX899 and concluded
that the study drugs were well tolerated and there were no
clinically relevant drug-drug interactions. About Idenix 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 and other
infectious diseases. Idenix's current focus is on the treatment of
infections caused by hepatitis C virus and HIV. For further
information about Idenix, please refer to http://www.idenix.com/.
Forward-looking Statements This press release contains
"forward-looking statements" within the meaning of The Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements can be identified by the use of forward-looking
terminology such as "anticipate," "could," "may," "will," or
similar expressions, or by express or implied statements with
respect to the company's clinical development programs in HIV, or
any potential pipeline candidates for the treatment of HIV,
including any expressed or implied statement regarding the efficacy
and safety of IDX899 and any future clinical trials involving
IDX899. 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. 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. In particular, management's expectations could
be affected by unexpected regulatory actions or delays;
uncertainties relating to, or unsuccessful results of, pre-clinical
studies and/or clinical trials, including additional data relating
to the ongoing pre-clinical studies and/or clinical trials
evaluating its product candidates, including IDX899; 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 Novartis Pharma AG;
changes in the company's business plan or objectives; the ability
of the company to attract and retain qualified personnel;
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. These
and other risks which may impact management's expectations are
described in greater detail under the caption "Risk Factors" in the
company's annual report on Form 10-K for the year ended December
31, 2007 and the Quarterly Report on Form 10-Q for the quarter
ended June 30, 2008, each as filed with the Securities and Exchange
Commission (SEC) and other filings that the company makes with the
SEC. All forward-looking statements reflect the company's
expectations only as of the date of this release 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. Idenix
anticipates that subsequent events and developments may cause these
views, expectations and beliefs to change. However, while Idenix
may elect to update these forward-looking statements at some point
in the future, it specifically disclaims any obligation to do so.
Amplicor(R) is a registered trademark of F. Hoffman-La Roche Ltd.
Reyataz(R) is a registered trademark of Bristol-Myers Squibb
Company. Truvada(R) is a registered trademark of Gilead Sciences,
Inc. Idenix Pharmaceuticals Contacts: Amy Sullivan 617-995-9838
(investors) Teri Dahlman 617-995-9905 (media) DATASOURCE: Idenix
Pharmaceuticals, Inc. CONTACT: Amy Sullivan, +1-617-995-9838
(investors) or Teri Dahlman, +1-617-995-9905 (media), both for
Idenix Pharmaceuticals, Inc. Web site: http://www.idenix.com/
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