Company Overview of Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc., a biopharmaceutical company, develops therapies to enhance treatment outcomes by optimizing and improving the administration and tolerability of drug therapies. The company develops ITCA 650, a Phase 3 clinical program for type 2 diabetes that consists of 4 separate clinical trials. Its products include a cylindrical titanium alloy reservoir that is inserted under the skin that allows the water from the extracellular fluid to enter the device at one end by diffusing through a semi-permeable membrane directly into a salt osmotic engine that expands to drive a piston at a controlled rate, and forces the drug formulation to be released in a consistent way through th...
155 Seaport Boulevard
Boston, MA 02210
Founded in 1995
Key Executives for Intarcia Therapeutics, Inc.
Executive Chairman, Chief Executive Officer and President
Chief Financial Officer and Vice President of Finance & Operations
Chief Scientific Officer and Vice President
Chief Legal Officer, Vice President and General Counsel
Compensation as of Fiscal Year 2016.
Intarcia Therapeutics, Inc. Key Developments
Intarcia Therapeutics, Inc. Presents at 35th Annual JP Morgan Healthcare Conference, Jan-09-2017 08:00 AM
Jan 6 17
Intarcia Therapeutics, Inc. Presents at 35th Annual JP Morgan Healthcare Conference, Jan-09-2017 08:00 AM. Venue: Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA 94102, United States. Speakers: Kurt C. Graves, Executive Chairman, Chief Executive Officer and President.
Intarcia Therapeutics, Inc. Submits New Drug Application to FDA for U.S. Marketing Approval of ITCA 650 in Type 2 Diabetes
Nov 21 16
Intarcia Therapeutics, Inc. announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ITCA 650 for the treatment of type 2 diabetes (T2D). If approved, ITCA 650 would become the first and only injection-free glucagon-like peptide-1 (GLP-1) receptor agonist therapy. ITCA 650 provides consistent and continuous subcutaneous delivery of exenatide via an osmotic mini-pump placed just under the skin in a simple in-office procedure that only takes a healthcare provider a few minutes to perform. ITCA 650 mini-pumps were given with a 20mcg/day three-month introductory dose and then followed by a 60mcg/day six-month maintenance dose. Twelve-month mini-pumps at the 60mcg/day maintenance dose are also in development. FREEDOM is a global clinical trial development program made up of four Phase 3 studies of ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes (T2D). The FREEDOM-1, FREEDOM-1 HBL, FREEDOM-2, and FREEDOM-CVO trials were successfully completed and met all primary and secondary endpoints. Results include demonstrating superior efficacy versus placebo and versus market leader, Januvia®. The overall FREEDOM program enrolled more than 5,000 subjects at over 500 clinical investigation sites in more than 30 countries to support U.S., EU and ROW regulatory filings.
Intarcia Therapeutics, Inc. Presents Positive Results from its Freedom-2 Clinical Trial with its Late-Stage Investigational Candidate ITCA 650
Jun 12 16
Intarcia Therapeutics, Inc. presented positive results from its FREEDOM-2 clinical trial with its late-stage investigational candidate ITCA 650, an injection-free GLP-1 receptor agonist that provides consistent and continuous delivery of exenatide via an osmotic mini-pump that is placed under the skin. ITCA 650 demonstrated superior efficacy to Januvia® in reducing HbA1c and body weight in patients with poorly controlled type 2 diabetes on metformin following one year of treatment. ITCA 650 met all primary and secondary trial endpoints. Significantly greater reductions were seen with ITCA 650 compared to Januvia for both HbA1c and weight early after the initiation of treatment and persisted over the entire 52 weeks. The data was presented in an oral presentation at the 76th Scientific Sessions of the American Diabetes Association. In the study, significantly more patients on ITCA 650 60 mcg versus Januvia 100 mg achieved the ADA-recommended HbA1c target of <7.0% (61% versus 42%; p<0.001). An even more dramatic difference occurred in the composite endpoint of HbA1c reductions of greater than or equal to 0.5% and weight reductions of 2 kg (4.4lbs) or greater (61% versus 28%; p<0.001). Baseline characteristics collected for each participant prior to the trial were similar, with an average age of 55 years, HbA1c level of 8.6%, body mass index (BMI) of 32.6 kg/m2 and duration since type 2 diabetes diagnosis of 8.3 years. In patients treated with ITCA 650, rescue therapy was required in 15% of patients compared to 35% of patients treated with Januvia. In the FREEDOM-2 trial, ITCA 650 60mcg also demonstrated a tolerability profile similar to the FREEDOM-1 placebo-controlled trial presented at ADA 2015. Discontinuations for nausea were in the low single digits over the full 12 months of treatment. There were no cases of major hypoglycemia in either study arm and minor events of hypoglycemia were reported in the low single digits for both study arms. The placements and removals of ITCA 650 were very well tolerated and the rate of minor infections at the placement site was less than 1% of all procedures in the trial. Intarcia announced last month the successful completion of its fourth and last Phase 3 clinical trial for ITCA 650; the FREEDOM cardiovascular outcome safety study of more than 4,000 patients achieved its primary and secondary endpoints, and the clinical results necessary for regulatory filing. All four Phase 3 clinical trials comprising the FREEDOM Program successfully met their clinical trial endpoints. Filing in the U.S. is expected by the end of third quarter 2016. Methodology and Scope of the FREEDOM-2 Clinical Trial: 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 adult patients with HbA1c levels >7.5% and <10.5%. Patients were on background metformin monotherapy and randomized 1:1 to receive either ITCA 650 60 mcg/day following an introductory dose of ITCA 650 20 mcg/day or once-daily oral Januvia 100 mg/day. The primary endpoint was change in HbA1c between Week 52 and Day 0. Secondary endpoints included the proportion of patients with a decrease in HbA1c of >0.5% and >2 kg weight loss between Week 52 and Day 0, change in body weight between Week 52 and Day 0 and proportion of patients with HbA1c <7% measured at Week 52. Intarcia presented the full results from its successfully completed FREEDOM-1 and FREEDOM-1 HBL (high baseline) Phase 3 clinical trials last year at the 75th Scientific Sessions of the American Diabetes Association and recently announced topline results from its fourth and final Phase 3 trial, FREEDOM-CVO, which met all of its primary and secondary endpoints.
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