Positive phase III results for ITCA 650 in Type 2 Diabetes- Intarcia Therapeutics

Results from the first two Phase III clinical trials (FREEDOM-1 and FREEDOM-1 HBL) of ITCA 650 (exenatide delivered continuously), from Intarcia Therapeutics, show positive data on key endpoints in Type 2 Diabetes. FREEDOM-1 demonstrated positive results for ITCA 650 when added to diet and exercise with or without standard oral diabetes medications, for those patients who were not at goal. All key endpoints were met, including significant reductions in HbA1c and weight, and the percentage of patients treated to goal. The drug produced significant and sustained mean reductions in HbA1c of 1.4% at 39 weeks of treatment (mITT population). Significant and progressive weight loss that was dose dependent was observed over 39 weeks (mITT population).

Patients on the primary Phase III dosing regimen lost a mean of 4 kg in the 60 mcg/d ITCA 650 dose group vs. 2 kg in the placebo group at Week 39, which was statistically significant. The overall tolerability profiles, including G.I. events, were very similar between the 40 mcg/d and the higher 60 mcg/d dose groups. There was a low single-digit discontinuation rate for nausea. No new safety findings were identified. Data were presented at the 75th Scientific Sessions of the American Diabetes Association.