Phenomix starts phase 1a trial of hepatitis C protease inhibitor

Oct 28 2008

Phenomix Corporation today announced it has begun administering subjects in a Phase 1a clinical trial of PHX1766, the company's internally discovered, orally available NS3/4A protease inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.

The study is being conducted at clinical sites in the Netherlands and will enroll approximately 24 healthy subjects and six HCV infected patients.

In this double-blind, randomized, placebo-controlled Phase 1a study, subjects will be treated with single ascending doses of PHX1766 in order to assess safety, tolerability and pharmacokinetics. Additionally, reductions in viral load will be measured in the patients with HCV infection.

"Phenomix initiated its HCV protease inhibitor program in August 2005 and just two years later we selected PHX1766 as our clinical candidate," said Julie Cherrington, Ph.D., president of Phenomix. "We expedited our HCV discovery program and have designed a unique Phase 1a program in order to obtain single day safety, tolerability and viral load information for PHX1766. We believe our HCV protease inhibitor PHX1766 will be distinguished by its favorable dosing, potency and selectivity attributes."

The World Health Organization estimates that nearly 180 million people worldwide are infected with HCV. Of these individuals, 130 million are chronic HCV carriers with an increased risk of developing liver cirrhosis or liver cancer. It is estimated that three to four million people worldwide are newly infected each year, 70 percent of whom will develop chronic hepatitis C. In response to the limitations of existing treatments for HCV infection, NS3/4A protease inhibitors have emerged as a potential alternative to the standard treatment.