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Positive Results Reported for Investigational Drug ITCA 650 in Diabetes Patients
Positive results have been reported from a phase III study conducted to compare the efficacy of a late-stage investigational candidate, ITCA 650 (Intarcia Therapeutics, Inc.), with that of sitagliptin (Januvia, Merck) in reducing hemoglobin A1c (HbA1c) in patients with type-2 diabetes after 1 year of treatment. All of the subjects received background metformin monotherapy.
ITCA 650 is an injection-free glucagon-like peptide-1 (GLP-1) receptor agonist that continuously delivers exenatide with once- or twice-yearly dosing via a matchstick-size, subdermally placed osmotic “mini-pump.” If approved by the FDA, ITCA 650 would be the first injection-free GLP-1 therapy capable of delivering up to 1 year of treatment from a single subdermal pump. The drug is currently being investigated in a global phase III clinical trial program called FREEDOM.
FREEDOM-2 was a multicenter, randomized, active-comparator, double-blind, global study with a 52-week treatment period and a 4-week post-treatment follow-up period. The trial involved 535 adult patients with HbA1c levels of between 7.5% and 10.5%. The patients received background metformin monotherapy in addition to treatment with either ITCA 650 (60 mcg/day) following an introductory dose of ITCA 650 (20 mcg/day), plus once-daily oral placebo, or once-daily oral sitagliptin (100 mg/day) plus placebo. The study’s primary endpoint was the change in HbA1c between week 52 and day 0. With superiority demonstrated, secondary endpoints included the proportion of patients with a decrease in HbA1c of greater than 0.5% and weight loss of greater than or equal to 2 kg between week 52 and day 0; the change in body weight between week 52 and day 0; and the proportion of patients with HbA1c of less than 7% measured at week 52.
ITCA 650 met all of the study’s primary and secondary endpoints, demonstrating superiority over sitagliptin at all time points through and including week 52 for reductions in HbA1c and in body weight. ITCA 650 is not being investigated for the management of obesity. Key study findings included the following:
- Significantly more patients receiving ITCA 650 (60 mcg/day) compared with sitagliptin (100 mg/day) achieved the study’s secondary composite endpoint, which combined glucose reductions of greater than 0.5% and weight reductions of 2 kg or greater.
- Significantly more patients receiving ITCA 650 (60 mcg/day) achieved the American Diabetes Association-recommended HbA1c target of less than 7.0% compared with sitaglitpin (100 mg/day).
Discontinuations for nausea were in the low single digits during the 12 months of treatment. There were no cases of major hypoglycemia in either treatment arm, and minor events of hypoglycemia were reported in the low single digits in both arms. Placement and removal of the ITCA 650 mini-pump were well-tolerated.
Source: Intarcia Therapeutics; August 18, 2015.