Intarcia Therapeutics announced positive top-line results from its Phase 3 FREEDOM-2 clinical trial to determine the comparative efficacy of its late-stage investigational candidate ITCA 650 to sitagliptinin (Januvia; Merck) reducing HbA1c in patients with type 2 diabetes following a year of treatment.

FREEDOM-2 was a multi-center, randomized, active comparator, double-blind, global Phase 3 trial with a 52-week treatment and a 4-week post-treatment follow-up period. The trial enrolled 535 adults with HbA1c levels ≥7.5% and ≤10.5%. Patients were on background metformin monotherapy and randomized 1:1 to receive either ITCA 650 60mcg/day following an introductory dose of ITCA 650 20mcg/day, plus once-daily oral placebo, or once-daily oral sitagliptin 100mg/day, plus ITCA 650 placebo. The primary endpoint was change in HbA1c between Week 52 and Day 0.

In the trial, ITCA 650 met all primary and secondary endpoints, demonstrating superiority over sitagliptinat every measured time point through and including week 52 endpoints for reduction in HbA1c and reduction in body weight (BW). Significantly more patients on ITCA 650 60mcg achieved the ADA-recommended HbA1c target of <7% vs. sitagliptin 100mg.

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ITCA 650 is an injection-free glucagon-like peptide-1 (GLP-1) receptor agonist that continuously delivers exenatide with just once or twice-yearly dosing via Intarcia’s proprietary technology platform involving a small matchstick-size subdermally placed osmotic mini-pump and its proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time. Exenatide, the active agent, is a GLP-1 receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes.

If approved, ITCA 650 would represent the first injection-free GLP-1 therapy capable of delivering up to a full year of treatment from a single subdermal placement.

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