Drug TMC649128 Enters Phase 1b
A new HCV polymerase inhibitor, TMC649128, is now being tested
in a Phase 1b trial, the first stage of evaluating safety
and efficacy in a large number of patients.
advent of direct-acting antiviral agents will revolutionize treatment
for hepatitis C virus (HCV) infection. The first 2 HCV protease
boceprevir (Victrelis) and telaprevir
(Incivek) -- were approved last month.
these drugs will initially be used in combination with pegylated
interferon/ribavirin, the goal is all-oral regimens combining
drugs that target different steps of the HCV lifecycle. TMC649128,
a nucleoside analog, is one of several HCV NS5B polymerase inhibitors
is an edited excerpt from a press release describing the new trial
issued by Medivir, which is developing TMC649128 in collaboration
with Tibotec, now known as Janssen.
Enters Phase Ib Trial in Patients Chronically
Infected with Genotype 1 Hepatitis C Virus
Sweden -- June 22, 2011 -- Medivir AB (OMX: MVIR), the emerging
research-based specialty pharmaceutical company focused on infectious
diseases, today announces the start of a phase Ib clinical trial
with TMC649128 intended for the treatment of chronic hepatitis
C virus (HCV) infection.
TMC649128 is a nucleoside NS5B polymerase inhibitor developed
in collaboration with Tibotec Pharmaceuticals. TMC649128 has demonstrated
an attractive pre-clinical profile and displays in vitro activity
across multiple HCV genotypes and a high genetic barrier to resistance.
A clinical phase Ia double-blind, randomized, placebo-controlled
single-ascending dose trial to assess the safety, tolerability
and pharmacokinetics in healthy volunteers has now successfully
The TMC649128 phase Ib study that now is underway is a double-blind,
randomized and placebo-controlled trial in genotype 1 HCV-infected
patients to evaluate the safety, tolerability, pharmacokinetics
and antiviral activity of multiple ascending doses of TMC649128
given as monotherapy and in combination with pegylated interferon
It is anticipated that TMC649128 will be used in combination with
other HCV direct acting antiviral agents, given its high genetic
barrier to resistance and antiviral activity across multiple HCV
"We are delighted to see TMC649128, our first HCV nucleoside
inhibitor, advance into clinical phase Ib studies in HCV patients",
stated Bertil Samuelsson, CSO of Medivir. "The start of this
phase Ib trial underscores our commitment to develop new and innovative
treatments for hepatitis C infected patients. We view nucleoside
inhibitors, such as TMC649128, and protease inhibitors, such as
TMC435, as cornerstone components of future direct acting antiviral
combinations for HCV therapy."
is an emerging research-based specialty pharmaceutical company
focused on the development of high-value treatments for infectious
diseases. Medivir has world class expertise in polymerase and
protease drug targets and drug development. Medivir has a strong
R&D portfolio and has recently launched its first product
Xerese/Xerclear. Medivir's key pipeline asset, TMC435, a protease
inhibitor, is in global phase 3 clinical development for Hepatitis
C and is partnered with Tibotec Pharmaceuticals.
For more information about Medivir, please visit the Company's
AB. TMC649128 enters Phase Ib Trial in Patients Chronically Infected
with Genotype-1 Hepatitis C Virus. Press release. June 22, 2011.