Shionogi-ViiV Healthcare LLC today announced that it will be progressing its once-daily, unboosted investigational integrase inhibitor, S/GSK1349572 ('572) into Phase III clinical trials. '572 will be the only once-daily, unboosted integrase inhibitor in Phase III clinical development.
This decision is based on promising results from two Phase IIb trials, SPRING-1 and VIKING, which are being presented this week at the XVIII International AIDS Conference in Vienna, Austria (Abstract Numbers THLBB205 & MOAB0105). These trials explored the efficacy of '572 in treatment-naive HIV subjects as well as in treatment-experienced subjects resistant to raltegravir. Further study in Phase III is necessary to determine conclusively the safety, efficacy and resistance profile of '572.
"ViiV Healthcare is committed to developing promising new options for the treatment of HIV. As a once-daily, unboosted integrase inhibitor, '572 could be an important new therapy to help people living with HIV," stated Dr. Dominique Limet, Chief Executive Officer, ViiV Healthcare. "'572 has the potential to offer naive and experienced patients a new option, one which in Phase II has shown positive antiviral activity and resistance results once a day. We hope to explore the potential further in the Phase III studies, which are expected to begin this year."
"We are very pleased with the progress of '572 in collaboration with ViiV Healthcare. Reaching the important milestone of initiating Phase III studies is a credit to the hard work and commitment of teams in both Shionogi and ViiV Healthcare. We look forward to starting the Phase III program for '572 and demonstrating its potential to benefit HIV infected patients across the treatment spectrum," said Dr. Sapan Shah, President & CEO, Shionogi Inc.
Shionogi-ViiV Healthcare LLC