Dear Friends;
This has been a good week for news in the Hepatitis Community ... here is the
release from Idenix Pharmaceuticals this week ... let's remember that time
will tell, but it's certainly reason to be hopeful that new answers are
coming ...
IDENIX PHARMACEUTICALS
Press
FOR IMMEDIATE RELEASE
Contact:
Idenix Pharmaceuticals, Inc. Euro RSCG Life NRP
(617) 250-3119 (212) 845-4200
Teri Babine Amy Garay (investor) ext. 4261
Idenix Public Relations Lynn Blenkhorn (media)
ext. 4276
IDENIX PRESENTS POSITIVE HEPATITIS C AND HEPATITIS B RESULTS
- Positive data advance hepatitis C candidate into phase I/II trial and
trigger start of phase III pivotal trial of telbivudine for HBV -
Sydney, AUSTRALIA, April 9, 2003 - Idenix Pharmaceuticals, Inc. today
presented positive pre-clinical results of NM283, its hepatitis C virus (HCV)
clinical drug candidate, at the 11th International Symposium on Viral
Hepatitis & Liver Disease in Sydney, Australia. NM283, a ribonucleoside
analog being developed as an oral, once-daily treatment, appeared to be well
tolerated and after one week of treatment reduced mean viral load by over 90
percent (1 log10) in a primate model of human chronic HCV infection. Idenix
also presented 24-week data from an ongoing phase IIb trial of telbivudine
(LdT) for the treatment of hepatitis B virus (HBV) infection, further
demonstrating its promising safety and antiviral efficacy. On the basis of
these results, Idenix has advanced NM283 to phase I/II clinical development
and initiated a phase III registration trial of telbivudine.
These data presentations follow Idenix's announcement in late March that it
has entered into definitive agreements with Novartis Pharma AG, an affiliate
of Novartis AG (NYSE:NVS), pursuant to which Novartis will acquire a majority
equity interest in Idenix and will acquire rights to jointly develop and
commercialize select Idenix drug candidates.
The NM283 preclinical study was conducted in a primate model with
human-derived chronic HCV infection. NM283 was administered orally,
once-daily for one week at either 8.3 or 16.6 mg/kg compared to placebo. HCV
viral loads dropped rapidly in all treated animals after the first two days
of dosing and fell further by day 7. Mean log10 viral load reductions at day
7 were 1.05 in the 16.6 mg/kg dose group and 0.83 in the 8.3 mg/kg dose
group. In contrast, HCV titers were stable in the pre-treatment and placebo
samples. NM283 appeared to be well tolerated throughout dosing. A phase I/II
clinical trial of NM283 in patients with chronic hepatitis C is now underway,
following the acceptance by the United States FDA of an Investigational New
Drug Application.
"We believe that NM283 is the first small molecule antiviral agent shown to
be effective in this primate model of chronic HCV infection", said David
Standring, Ph.D., Idenix's Vice President of Biology. "These results suggest
that further development of this potentially important new treatment for
chronic hepatitis C is warranted."
The phase I/II clinical trial of NM283 will evaluate safety and antiviral
activity in adults with genotype 1 HCV infection to determine optimal dosing
levels of NM283 for future clinical trials. This short-term dose-escalation
trial is being conducted at a number of sites in the United States.
HBV Program - Telbivudine
Data from an ongoing phase IIb clinical trial of telbivudine (LdT) for the
treatment of chronic hepatitis B were also presented today by Ching-Lung Lai,
M.D., Professor of Medicine at the University of Hong Kong and a principal
investigator in this study. This randomized, blinded, international
multicenter phase IIb clinical trial, in 104 adults with HBeAg-positive
chronic hepatitis B, compares the safety and antiviral efficacy of
telbivudine, and telbivudine in combination with lamivudine, to a control arm
of lamivudine alone. All patients are being dosed orally, once-daily for a
treatment period of 52 weeks.
Average reductions in serum virus load were greater than 6 log10 for all
trial groups receiving LdT, significantly greater than the 4.67 log10
reduction observed with lamivudine alone. Serum HBV became undetectable in
twice as many patients receiving LdT monotherapy, compared with lamivudine
monotherapy, as determined by a highly sensitive polymerase chain reaction
(PCR) assay (32% and 16%, respectively). Within 12 weeks of treatment, 49% of
patients receiving LdT monotherapy had normalized serum alanine
aminotransferase (ALT), indicating reduced liver inflammation. By week 24,
ALT had normalized in 75% of patients receiving LdT monotherapy. LdT
treatments have been well tolerated, with no treatment-related or
dose-limiting adverse events observed. Final 52-week phase IIb data are
expected in the fall of this year.
These promising data support the initiation of a large-scale international
phase III clinical trial, currently underway. This pivotal registration
trial, enrolling 1,200 patients worldwide, will evaluate the safety and
efficacy of telbivudine compared with lamivudine, in patients with
HBeAg-positive and HBeAg-negative compensated liver disease.
Idenix recently announced that it had entered into definitive agreements with
Novartis Pharma AG. Upon closing of the agreements, Novartis will acquire 51%
of the issued and outstanding shares of Idenix and rights to jointly develop
and commercialize Idenix's hepatitis B clinical drug candidates. Novartis
will also have the option to acquire rights to Idenix's hepatitis C drug
candidates. '
'
About hepatitis C:
There are approximately 170 million people worldwide with chronic HCV
infection, of which approximately 3 million are in the United States. HCV
accounts for 30% of end-stage liver disease and liver cancer, 20% of
cirrhosis cases and is the leading cause of liver transplant. Available
treatment options are limited in their effectiveness and safety.
Additionally, these therapies are less effective in patients infected with
HCV genotype 1, a specific strain of HCV that is the most prevalent and most
treatment-resistant HCV genotype found in the US, Japan and Western Europe.
About hepatitis B:
There are approximately 350 million people worldwide with chronic hepatitis B
virus infection, of whom approximately 33% have potentially progressive and
life-threatening liver disease associated with their chronic HBV infection.
Chronic hepatitis B can lead to cirrhosis, liver failure and hepatocellular
carcinoma (liver cancer). Globally, hepatitis B accounts for over one million
deaths annually, making it the ninth leading cause of death worldwide.
'
About Idenix:
Idenix Pharmaceuticals is engaged in the discovery and development of
selective and specific, small molecule drug candidates which may be
administered orally, once-daily, alone or as components of combination drug
therapy for infectious disease. The Company is headquartered in Cambridge,
Massachusetts and has drug discovery operations in Montpellier, France and
Cagliari, Italy. Idenix's current focus is on the treatment of infections
caused by hepatitis B virus, hepatitis C virus and human immunodeficiency
virus (HIV). For further information, please refer to http://www.idenix.com.
Although only time will tell how successful these treatments will be, it's
certainly a bright spot in the week for all of us. Let's keep thinking good
thoughts, sending good vibes and keeping that hope alive.
