- Idenix Reports Positive Proof-of-Concept Data for Lead
Nucleotide Prodrug, IDX21437
- Idenix on Track to Initiate All-Oral Pan-Genotypic Phase II
Combination Clinical Study of IDX21437 and Samatasvir in
mid-2014
- Idenix Initiates Phase I Clinical Trial of Follow-on Nucleotide
Prodrug, IDX21459
- Idenix to Host Conference Call / Webcast at 8:00 a.m. ET
today
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical
company engaged in the discovery and development of drugs for the
treatment of human viral diseases, today announced continued
progress of the Company's program to develop nucleotide prodrug
inhibitors for the treatment of hepatitis C virus (HCV) infection.
Idenix is reporting potent antiviral activity of mean maximum
4.2-4.3 log10 IU/mL reductions for patients infected with HCV
genotype 1, 2 or 3 receiving 300 mg once daily of IDX21437 in the
seven-day proof-of-concept portion of a phase I/II clinical trial.
Based on this progress, the Company's goal is to initiate a
combination clinical trial of IDX21437 and samatasvir, a
pan-genotypic NS5A inhibitor, in mid-2014. In addition, Idenix has
selected a follow-on uridine-based nucleotide prodrug, IDX21459,
from its ongoing nucleotide discovery program and initiated
enrollment for the healthy volunteer portion of a phase I clinical
trial.
"As more all-oral regimens become available to treat hepatitis
C, an increased number of patients will be diagnosed and treated.
It will be important to have simple, short duration options for our
patients. These early data for IDX21437 support its potential to be
part of future treatment combinations." said Professor Edward Gane,
MD, Deputy Director and Hepatologist, New Zealand Liver Transplant
Unit, Auckland City Hospital in New Zealand, and a clinical
investigator in the IDX21437 proof-of-concept study.
"Nucleotide-based treatment combinations are favored because of
safety, efficacy, high barrier to resistance and low drug-drug
interaction potential and we look forward to seeing further results
from studies with IDX21437."
"We are very pleased with these positive data for IDX21437 and
we are excited to have two nucleotide prodrug candidates in the
clinic," said Ron Renaud, Idenix's President and Chief Executive
Officer. "With the initiation of the phase II study of
IDX21437 and samatasvir later this year, we will be one of a few
companies with an all-oral, pan-genotypic, nucleotide-based
combination approach in the clinic. We believe this regimen has the
potential to play a significant role in advancing HCV care for the
benefit of patients, physicians and payers."
IDX21437: Topline 7-Day Phase I/II Clinical
Results
In January 2014, Idenix initiated the seven-day proof-of-concept
portion of a phase I/II clinical trial for IDX21437. The trial
completed enrollment of 44 treatment-naïve, genotype (GT) 1, 2 or 3
HCV-infected patients. Patients were randomized to receive
once-daily doses of placebo, 50 mg, 150 mg, or 300 mg of IDX21437
for seven days. The topline clinical results include:
- IDX21437 was well-tolerated with no observed pattern of adverse
events or laboratory abnormalities.
- Treatment with IDX21437 exhibited potent pan-genotypic activity
in a dose-dependent manner:
- In GT 1 HCV-infected patients (n=8), the mean maximal viral
load reduction was 4.2 log10 IU/mL in the 300 mg arm.
- The mean maximal viral load reduction of 4.3 log10 IU/mL was
achieved in GT 2 and 3 HCV-infected patients in the 300 mg arm
(n=10).
- More detailed findings are expected to be presented at a future
scientific meeting.
- Based on these findings, the 300 mg dose of IDX21437 has been
chosen for the anticipated phase II combination study with
samatasvir.
IDX21459: Phase I Clinical Program
In April 2014, Idenix initiated enrollment for the healthy
volunteer portion of a phase I clinical trial of IDX21459 in
Europe. This portion of the study is expected to enroll
approximately 50 healthy volunteers and will evaluate once-daily
doses of IDX21459 ranging from 10 mg – 300 mg. The proof-of-concept
portion of the study is expected to enroll a total of 40
treatment-naïve, genotype 1 HCV-infected patients who will receive
once-daily doses of placebo, 50 - 300 mg of IDX21459 for seven
days. IDX21459 has shown a favorable preclinical profile including
potent, pan-genotypic activity and favorable safety with respect to
cardiac, mitochondrial and genotoxicity assessments.
Additional Nucleotide Candidates
Idenix's primary efforts in nucleotide development will continue
to focus on its lead candidate, IDX21437, and follow-on prodrug
candidate, IDX21459, as well as earlier-stage nucleotide prodrugs.
An important objective for the discovery program is to identify
nucleotides offering distinct resistance profiles that can be
combined with one of the Company's current nucleotide clinical
candidates to treat HCV. Idenix also announced today that the
Company has elected not to continue its clinical development
program for HCV nucleotide prodrug, IDX20963, previously placed on
clinical hold by the U.S. Food and Drug Administration
(FDA).
CONFERENCE CALL AND WEBCAST INFORMATION
Idenix management will host a conference call at 8:00 a.m. ET
today. To access the call, please dial (877) 640-9809
(U.S./Canada) or (914) 495-8528 (International) and enter passcode
26004979. A live webcast will be available through the
Investor section of the Idenix website at www.idenix.com under
"Events & Presentations". The archived webcast will be
available for two weeks following the call on the Idenix
website.
ABOUT IDX21437
IDX21437, Idenix's lead uridine-based nucleotide prodrug
inhibitor, has completed the single-dose and seven-day
proof-of-concept portions of a phase I/II clinical trial. Extensive
preclinical testing for IDX21437 has demonstrated favorable
antiviral activity across genotypes 1-6 and a safety profile which
supported advancement into clinical trials. Based on this progress,
the Company's goal is to initiate an Idenix-sponsored combination
clinical trial of IDX21437 and samatasvir in mid-2014.
ABOUT SAMATASVIR
Samatasvir is an NS5A inhibitor with low picomolar,
pan-genotypic antiviral activity in vitro. To date, samatasvir has
been safe and well-tolerated after single and multiple doses of up
to 150 mg in healthy volunteers up to 14 days duration, and in
HCV-infected patients up to 12 weeks duration. Samatasvir 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.
Under a non-exclusive collaboration with Janssen
Pharmaceuticals, Inc., Idenix is evaluating all-oral, direct-acting
antiviral HCV combination regimens including samatasvir, simeprevir
(TMC435), a once-daily protease inhibitor jointly developed by
Janssen R&D Ireland and Medivir AB, and TMC647055/r, a
once-daily non-nucleoside polymerase inhibitor boosted with
low-dose ritonavir being developed by Janssen. In this program,
Idenix is conducting two ongoing phase II 12-week clinical trials,
HELIX-1 and HELIX-2.
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 150 million people
worldwide are chronically infected with HCV, representing a nearly
5-fold greater prevalence than human immunodeficiency virus.
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
diseases. Idenix's current focus is on the treatment of
patients with hepatitis C infection. For further information
about Idenix, please refer to www.idenix.com.
FORWARD-LOOKING STATEMENTS
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 samatasvir,
IDX21437, IDX21459 or any other drug candidate; the successful
development of novel combinations of direct-acting antivirals for
the treatment of HCV; and the likelihood and success of any future
clinical trials involving samatasvir, IDX21437, IDX21459 or our
other drug candidates. 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; uncertainties relating to, or unsuccessful
results of, clinical trials, including additional data relating to
the ongoing clinical trials evaluating its product candidates; 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 December 31, 2013 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) 995-9807
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