Intarcia Therapeutics, Inc. today announced the start of enrollment for a phase 2 study comparing its proprietary drug candidate ITCA 650 (DUROS continuous delivery of exenatide) with Byetta, an FDA-approved twice-daily injection form of exenatide. Building upon the successful completion of a 28-day phase 1b study of ITCA 650 in May of this year, the phase 2 study is intended to evaluate the doses achieving the best results in the phase 1b in a larger study population and for a longer duration of treatment. In addition, an extension phase of the phase 2 study will evaluate dose response of ITCA 650. Patients receiving Byetta for the first 12 weeks will be switched from Byetta to one of two doses of ITCA 650 to evaluate the potential for improving treatment effect.
"We are very pleased with the rapid progress and positive results achieved thus far in the ITCA 650 program" said Ken Luskey, MD, VP, Clinical Research for Intarcia. "In 2009, we expect to move the ITCA 650 program from IND-filing through completion of phase 2 enrollment."
The ITCA 650 phase 2 study will involve 150 patients with sub-optimally controlled type 2 diabetes treated with metformin. Patients will be recruited at 50 clinical trial sites in the US and will be randomized equally to receive one of two doses of ITCA 650 or twice-daily injections of Byetta. Upon completion of the 12-week course of treatment, patients on all three arms will be further randomized to receive higher doses of ITCA 650 for an additional 12 weeks. The extension phase will evaluate efficacy and tolerability of higher doses of ITCA 650, as well as the effects of switching patients from twice-daily injections of Byetta to ITCA 650. The study will provide important information to support dose selection for ITCA 650 phase 3 evaluation, anticipated to begin in the second half of 2010. Additionally, this phase 2 study will provide important insights into future clinical use of ITCA 650 with respect to switching patients from injectable Byetta therapy to ITCA 650.
"We have received strong interest in the ITCA 650 program since the late-breaker presentation of preliminary phase 1b study results at the American Diabetes Association Conference in June" said K. Alice Leung, President and CEO of Intarcia. "We intend to select a commercial partner for ITCA 650 prior to the start of phase 3 in the second half of 2010."