Medivir AB the emerging research-based specialty pharmaceutical company focused on infectious diseases, announced the start of a phase I a clinical trial with TMC649128 intended for the treatment of chronic Hepatitis C Virus infection.

TMC649128 is a nucleoside NS5B polymerase inhibitor that has already demonstrated an attractive pre-clinical profile. It is anticipated that this profile would see TMC649128 be used in combination with HCV directly acting antiviral agents, given their high genetic barrier to resistance and antiviral activity across multiple HCV genotypes.

In pre-clinical studies, TMC649128 displayed in vitro activity across multiple HCV genotypes and a high genetic barrier to resistance.

The phase I a trial is a double-blind, randomized, placebo-controlled single-ascending dose trial to assess the safety, tolerability and pharmacokinetics in healthy volunteers and will be conducted in Belgium. TMC649128 is being developed in collaboration with Tibotec Pharmaceuticals.

Medivir entered a Research and Development agreement in the field of Hepatitis C Virus polymerase with Ortho Biotech Products LP, an affiliate of Tibotec in May 2008. The development of TMC649128 falls under this agreement and by entering clinical development, a milestone payment of Euro 7 million has been triggered for payment to Medivir.

“We are extremely excited to see TMC649128, our first HCV nucleoside inhibitor, move into clinical development”, stated Bertil Samuelsson, CSO of Medivir. “The start of this phase I a trial underlines Medivir’s commitment to the development of novel and innovative Hepatitis C treatments. 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.”

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 per cent 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.

Medivir and Tibotec are also jointly developing the once daily protease inhibitor TMC435 for treatment of Hepatitis C Virus infections (HCV).

Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Company has a strong R&D portfolio and has recently launched its first product Xerese/Xerclear.