Below
is the text of a press release issued by the company describing the current status
of the clinical trial:
Anadys
Pharmaceuticals Commences Dosing
in Phase II Study of ANA598
ANA598
To Be Dosed for 12 Weeks in Triple Combination
San
Diego -- September 9, 2009 -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced
today that dosing has begun in a Phase II trial of ANA598 in patients chronically
infected with hepatitis C virus (HCV). The study will evaluate ANA598 over 12
weeks, taken in combination with pegylated interferon-alpha and ribavirin, in
treatment naive HCV patients. ANA598 is an investigational, oral, non-nucleoside
polymerase inhibitor.
"ANA598
has demonstrated potent antiviral activity and good tolerability as a single agent,
as well as preclinical properties indicative of likely synergy when used clinically
in combination regimens," said James Freddo, MD, Anadys' Senior Vice President,
Drug Development and Chief Medical Officer. "We look forward to building
upon these results to demonstrate the benefit of ANA598 when used in combination
with interferon and ribavirin."
About
the Phase II Study
In
the Phase II study, naive genotype 1 patients will receive ANA598 or placebo in
combination with Pegasys (peginterferon alfa-2a)
and Copegus (ribavirin, USP) (a current standard of care, or SOC) for 12 weeks
at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose
of 800 mg bid on day one. After week 12, patients will continue to receive SOC.
Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized
to stop all treatment at week 24 or 48.
The
primary endpoint of the study is the proportion of patients with undetectable
virus at week 12 (defined as complete Early Virological Response, or cEVR). Additional
endpoints include safety and tolerability as well as the proportion of patients
with undetectable virus at week 4 (defined as Rapid Virological Response, or RVR),
weeks 24 and 48, and 24 weeks after stopping all treatment (defined as Sustained
Virological Response, or SVR).
Ninety
patients are planned to be enrolled in this study -- thirty patients receiving
ANA598 and fifteen receiving placebo at each dose level. The study will be managed
by the Duke Clinical Research Institute (DCRI) under the leadership of John McHutchison,
M.D. and will be conducted at a number of clinical sites in the United States.
Anadys
expects to receive 28-day safety and response (RVR) data from the 200 mg dose
level by year-end and additional on-treatment safety and response data from both
cohorts during the first two quarters of 2010.
About
ANA598
ANA598
is a non-nucleoside inhibitor of the HCV RNA polymerase. Anadys has completed
three Phase I clinical studies of ANA598 that have demonstrated potent antiviral
activity and good tolerability. In a monotherapy study in naive genotype 1 patients,
treatment with ANA598 for three days led to median declines in viral load ranging
from 2.4 to 2.9 log10 in three separate dose groups. No patient at any dose level
showed evidence of viral rebound while on ANA598, and there were no serious adverse
events.
Anadys
has completed dosing in two long-term chronic toxicology studies of ANA598 (26
weeks duration in rats and 39 weeks duration in monkeys). At the 13-week interim,
the toxicology profile of ANA598 in both species was very favorable. A preliminary
assessment of the results from the 26-week study in rats indicates a similar profile
to that seen in rats at 13 weeks, in which the only adverse finding was a marginal
decrease in the rate of weight gain in females at 1000 mg/kg, the highest dose
tested. Complete results from both studies, including 39-week data from the monkey
study, are expected at the end of the third quarter 2009.
Anadys
has presented results from multiple in vitro studies that support the clinical
use of ANA598 in combination with interferon-alpha. In particular, data have shown
that ANA598 is synergistic in vitro with interferon-alpha, that mutations conferring
resistance to ANA598 remain fully sensitive to interferon-alpha, and that synergy
between ANA598 and interferon-alpha is retained against mutations conferring resistance
to ANA598. Anadys has also presented in vitro results supporting future clinical
combination studies with direct antivirals, including a demonstration of in vitro
synergy between ANA598 and representative HCV protease and polymerase inhibitors.
Furthermore, Anadys has presented data that show ANA598 retains full activity
in vitro against mutations conferring resistance to protease inhibitors,
nucleoside polymerase inhibitors and non-nucleoside polymerase inhibitors that
act at binding sites distinct from that of ANA598, and that protease and nucleoside
polymerase inhibitors retain full activity in vitro against mutations conferring
resistance to ANA598.
ANA598
has received Fast Track Status from the FDA for the treatment of chronic hepatitis
C.
About
Anadys
Anadys
Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient
care by developing novel medicines for the treatment of hepatitis C. The company
believes hepatitis C represents a large unmet medical need in which meaningful
improvements in treatment outcomes may be attainable with the introduction of
new medicines. The company is developing ANA598, a non-nucleoside polymerase inhibitor
for the treatment of hepatitis C. The company has also investigated the potential
of ANA773, an oral, small-molecule inducer of endogenous interferons that acts
via the Toll-like receptor 7, or TLR7, pathway in hepatitis C.
For
more information, see http://www.anadyspharma.com.
9/15/09
Source
Anadys
Pharmaceuticals. Anadys Pharmaceuticals Commences Dosing in Phase II Study of
ANA598. Press release. September 9, 2009.
