TMC649128 enters Phase Ib Trial in Patients Chronically Infected with
Genotype-1 Hepatitis C Virus
Huddinge, Sweden - 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 been
completed.
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 and ribavirin.
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 genotypes.
“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.”
For more information about Medivir, please contact;
Medivir (www.medivir.se (http://www.medivir.se))
Mobile: +46 708 537 292
Rein Piir, CFO & VP Investor Relations
M:CommunicationsEurope: Mary-Jane Elliott / Amber Bielecka / Katja Toon
Medivir@mcomgroup.com (Medivir@mcomgroup.com)
+44(0)20 7920 2330
USA: Roland Tomforde
+1 212 232 2356
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a
leading cause of chronic liver disease and liver transplants. The WHO
estimates that nearly 180 million people worldwide, or approximately 3%
of the world's population, are infected with hepatitis C virus (HCV).
The CDC has reported that almost three million people in the United
States are chronically infected with HCV.
About Medivir's Commitment to HCV
Medivir and Tibotec are also jointly developing the once daily protease
inhibitor TMC435 for treatment of hepatitis C virus infections (HCV).
About Medivir
Medivir 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.
Xerese™/Xerclear® is an innovative treatment for cold sores, which has
been approved in both the US and Europe. It is partnered with
GlaxoSmithKline to be sold OTC in Europe and Russia and with Meda AB in
North America. Medivir has retained the Rx rights for Xerclear® in
Sweden and Finland.
For more information about Medivir, please visit the Company's website:
www.medivir.se.
TMC649128 enters Phase Ib Trial in Patients Chronically Infected with Genotype-1 Hepatitis C Virus
| Source: Medivir AB
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