InterMune Inc. has announced that it successfully completed large-scale synthesis and delivery to its partner Roche of active pharmaceutical ingredient for hepatitis C virus (HCV) drug candidate ITMN-191, currently in a phase 1a clinical trial.
The milestone triggered a $10 million payment to InterMune from Roche as part of the companies' collaboration to develop and commercialise novel protease inhibitors for the treatment of HCV.
"InterMune has successfully executed key steps in the manufacture of a very sophisticated protease inhibitor molecule and transferred the materials to Roche for future studies," said Lawrence M Blatt, PhD, chief scientific officer of InterMune. "We're pleased to have completed these crucial manufacturing-related activities and that our HCV clinical development programme that is partnered with Roche is off to an excellent start."
According to the Centres for Disease Control and Prevention (CDC), an estimated 3.9 million Americans (1.8 per cent) have been infected with HCV, of whom 2.7 million are chronically infected. According to the World Health Organization (WHO), it is estimated that there are 170 million people worldwide afflicted with this disease. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches.
ITMN-191, the lead HCV NS3/4A protease inhibitor compound from the InterMune discovery program, has demonstrated in preclinical studies its potential to be an important drug candidate because of its favourable cross resistance and potency profiles, as well as pharmacokinetic results that support the exploration of twice-daily oral dosing in HCV patients.
InterMune is a biotechnology company focused on the research, development and commercialisation of innovative therapies in pulmonology and hepatology.