InterMune is conducting the research in collaboration with Array BioPharma. Upon successful review, InterMune will initiate the phase I clinical program of ITMN-191.
Studies of ITMN-191 demonstrated a favorable safety and toxicology profile, allowing ITMN-191 to be studied in clinical trials over a range of doses predicted to have antiviral efficacy. ITMN-191 also displayed a favorable cross-resistance profile. The preclinical pharmacokinetic results reported in the CTA support the exploration of twice-daily dosing in the treatment of chronic hepatitis C.
“We are very pleased to have submitted the CTA for ITMN-191 on the schedule we set last January,” said Dan Welch, President and CEO of InterMune. “We look forward to securing the authorization to proceed with our first clinical trial of ITMN-191, which we anticipate to begin before the end of this year.”