BOSTON, Sept. 15, 2017 /PRNewswire/ -- Intarcia Therapeutics, Inc. announced top-line results from FREEDOM-3S which assessed the tolerability and optimal dosing regimen of two different ITCA 650 (exenatide in osmotic mini-pump) dosing approaches when switching patients with type 2 diabetes from stable therapy with liraglutide to ITCA 650. The trial demonstrated that patients receiving 1.2 or 1.8 mg of an injectable liraglutide treatment can be switched directly to the full dose six-month ITCA 650 60 mcg/day osmotic mini-pumps.
Patients tolerated the switch to ITCA 650 very well. There was also no statistically significant difference in safety or tolerability when switching directly to the full dose six-month 60 mcg/day mini-pumps versus first switching to the initial 20 mcg/day three-month mini-pumps followed by a 60 mcg/day six-month maintenance dose. Glycemic control remained stable over the 26-week treatment period after the switch to ITCA 650. Additionally, when patients switched from stable liraglutide 1.2 mg and 1.8 mg injections, an incremental and statistically significant reduction in weight from baseline was observed at week 26. The majority of patients entering the switch study were being treated with 1.8 mg injections of liraglutide.
Currently under review with the U.S. Food and Drug Administration (FDA), ITCA 650 is a novel investigational therapy that provides continuous delivery of exenatide via Intarcia's proprietary technology, the Medici Drug Delivery System™, an osmotic mini-pump placed just beneath a patient's skin in the abdominal wall that allows drug within the mini-pump to be released in a steady, consistent fashion for up to six months.
"Real-world outcomes data consistently shows that the majority of patients living with type 2 diabetes really struggle to adhere to chronic pills and injections and this translates directly into why diabetes is still a public health crisis spiraling out of control. This is the elephant in the room and it is not the patients' fault," said Kurt Graves, Chairman, President and CEO of Intarcia Therapeutics, Inc. "Intarcia's goal is to bring to type 2 diabetes patients, providers and payers a totally new way of delivering chronic GLP-1 therapy that is injection-free and dosed just twice per year initially, and eventually once per year. We're very pleased with the results of this study which demonstrate the optimal way to switch from the leading injectable GLP-1 to ITCA 650."
In prior phase three studies in patients already treated with oral antidiabetic medication and/or insulin, the dosing regimen of ITCA 650 was with an initiation dose of 20 mcg/day for three months. After three months at the lower initial dose, the maintenance dose was increased to 60 mcg/day administered with six-month mini-pumps. The six-month 60 mcg/day mini-pumps can be removed and replaced every six months thereafter.
This switch study was undertaken to evaluate whether patients who were already on an injectable GLP-1 receptor agonist required initiation with the lower starting dose of ITCA 650 before titrating up to the full dose longer duration mini-pumps or if these particular patients already on a stable dose of a GLP-1 receptor agonist could be switched straight to the six-month full dose 60 mcg/day mini-pumps without compromising GI tolerability and/or overall tolerability.
The study included 136 patients with type 2 diabetes across 37 U.S. trial sites, who were receiving chronic stable doses of liraglutide and metformin. Patients were randomized to receive the recommended ITCA 650 dosing regimen of 20 mcg/day for 13 weeks followed by 60 mcg/day for 13 weeks or 60 mcg/day of ITCA 650 for 26 weeks. The final dose of liraglutide was taken 48 hours prior to randomization and metformin was continued during the 26-week treatment period. Comparison of the tolerability of the two ITCA 650 dose regimens after switching from stable liraglutide treatment was the primary endpoint. Both treatment regimens were equally well tolerated. The majority of patients did not experience nausea or vomiting; the overall incidence over time being consistent with prior studies of ITCA 650, all mild to moderate in severity, and transient. No serious nausea or vomiting were reported. Discontinuation for nausea (0-1.5%) was very low. Overall safety and tolerability was consistent with prior phase three trials. In addition to these results, this FREEDOM-3S study incorporated an updated placement procedure guide that optimizes sub-dermal placement of the mini-pump that facilitates easy removal. This enhanced featured is the result of Intarcia's continuous commitment to product design and a focus on optimizing the patient and provider experiences with the proprietary Medici Drug Delivery System™. No new safety findings for ITCA 650 were identified.
"These findings support the safety and efficacy profile of ITCA 650 from the FREEDOM clinical development program, and provide important dosing information to assist healthcare providers in clinical decision making," said Michelle Baron, MD, Vice President of Clinical Research and Chief Medical Officer of Intarcia Therapeutics, Inc. "We look forward to presenting further details of the study data at a future date."
About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment and prevention outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. Delivering medicines just once- or twice yearly to prevent and/or chronically treat diseases holds potential to improve outcomes by improving effectiveness over time and by addressing real-world unmet needs around poor patient adherence and persistence rates in the majority of chronic diseases. Intarcia is investigating multiple therapies, including combination therapies, for chronic diseases leveraging the convergence of novel medicines and the proprietary Medici Drug Delivery System™. Intarcia is developing a strong pipeline in important therapeutic areas, including: diabetes, obesity, NASH, autoimmune diseases, HIV, and other serious chronic disorders.
Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc.
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SOURCE Intarcia Therapeutics, Inc.