or INX-189 for short, is a potent guanosine nucleotide polymerase
inhibitor for the treatment of chronic
hepatitis C, according to a press release issued by Inhibitex.
the FDA Modernization Act of 1997, the "Fast Track"
program is designed to facilitate the development and expedite
the review of new drugs that are intended to treat serious or
life-threatening conditions, and that demonstrate the potential
to address unmet medical needs.
The characteristics of INX-189 that contributed to its Fast Track
status include a high genetic barrier to resistance, activity
against multiple HCV genotypes, and once-daily oral dosing, the
"The FDA's Fast Track designation for INX-189 is reflective
of its unique features and the need for novel antiviral drugs
that demonstrate the potential to provide better clinical outcomes
and improved tolerability for the millions of individuals suffering
from chronic hepatitis C infection," said Joseph Patti, Chief
Scientific Officer and Senior Vice President of Research and Development
The company has reported interim data from the first 2 cohorts
of an ongoing Phase 1b clinical trial of INX-189, and expects
to complete this trial by the end of March.
The full Inhibitex press release is available
online. For additional information about the company, visit
Medivir AB announced earlier this months that it has started a
Phase 1a clinical trial of TMC649128 for the treatment of chronic
TMC649128, which is being developed in collaboration with Tibotec
Pharmaceuticals, is a nucleoside NS5B polymerase inhibitor that
has already demonstrated an attractive pre-clinical profile, according
to a Medivir press release. In laboratory studies TMC649128 demonstrated
activity against multiple HCV genotypes and had a high genetic
barrier to resistance.
The new Phase 1a study is a double-blind, randomized, placebo-controlled
single-ascending dose trial to assess the safety, tolerability,
and pharmacokinetics of TMC649128 in healthy HCV-uninfected volunteers.
"We are extremely excited to see TMC649128, our first HCV
nucleoside inhibitor, move into clinical development," said
Bertil Samuelsson, CSO of Medivir. "We view nucleoside inhibitors
as cornerstone components of future HCV treatment paradigms in
combination with directly acting antiviral agents and a TMC649128
component could set them apart from other HCV drug classes."
The full press release is available
online. For more information about Medivir, visit the company's
website at www.medivir.se.
Inc. Inhibitex Receives Fast Track Designation for INX-189 for
the Treatment of Chronic Hepatitis C Infections. Press
release. February 11, 2011.
Announces Start of Phase 1a Trial of the Hepatitis C Polymerase
Inhibitor TMC649128. Press
release. February 10, 2011.