− FREEDOM-CVO Phase 3 safety trial in more than 4,000 patients meets its primary and secondary endpoints by demonstrating FDA required non-inferiority for pre-approval cardiovascular (CV) safety. Final data to be published and presented at major future medical meeting. −
− Comprehensive Phase 3 data and manufacturing data packages will be in hand during 3Q; Regulatory filing targeted for the end of 3Q 2016 in the U.S. −
Boston, MA – May 6, 2016 – Intarcia Therapeutics, Inc. today announced top-line results from its more than 4,000 patient Cardiovascular Safety Study (FREEDOM-CVO trial), clearing the last major clinical hurdle in the global FREEDOM Phase 3 Clinical Trial Program that started in early 2013. Regulatory filing in the U.S. is targeted for end of 3Q, 2016. The Company also announced a $75 million round of debt financing timed to facilitate ongoing scale-up of manufacturing and the production of inventory for the anticipated global launch of ITCA 650 in type 2 diabetes. The new credit facility is with MidCap Financial and Silicon Valley Bank.
"The completion of our FREEDOM-CVO safety trial is the most recent of four consecutive and successful clinical milestones for Intarcia, marking the end of our large pivotal Phase 3 trials required for the regulatory submissions for ITCA 650, said Dr. Michelle Baron, Chief Medical Officer for Diabetes at Intarcia Therapeutics. “The FREEDOM-CVO trial was designed to test CV safety in a pre-approval setting, and we are pleased that it has achieved all of its clinical endpoints and was completed on time. We look forward to working closely with global health authorities as we rapidly prepare for our regulatory submissions and reviews."
Kurt Graves, Chairman, President and CEO of Intarcia Therapeutics added, “The FREEDOM Phase 3 Clinical Trial Program for ITCA 650 has come to a close at an exciting and auspicious time in the GLP-1 receptor agonist category: A time when our global phase 3 program has successfully completed, and a time when new medical evidence from larger and longer-term trials is just emerging showing that GLP-1 receptor agonists may provide potential cardiovascular benefit to patients. Against this backdrop and an accelerating growth trajectory and outlook for the GLP-1 class of medicines, we’re right where we wanted to be when we started this mission nearly ten years ago. That is because we fundamentally designed and investigated ITCA 650 to address future unmet needs and opportunities with type 2 diabetes patients in mind. ITCA 650 represents the first and only once or twice-yearly GLP-1 in development: a totally differentiated approach for chronic medicine delivery that we aim to show can bring important potential benefits to patients, payers and providers who seek earlier and better control of type 2 diabetes, dramatically improved medication adherence and control rates over time, and an important alternative to life-long self-injections of GLP-1s and pills that the vast majority of patients with diabetes struggle to persist with after just six months of initiating therapy."
Methodology and Scope of the FREEDOM-CVO Clinical Trial
The FREEDOM-CVO Safety Trial is the fourth and final Phase 3 clinical trial of the FREEDOM program. It is a global, placebo-controlled cardiovascular outcomes study designed to meet the pre-approval safety assessment requirements set out in the U.S. Food and Drug Administration’s Guidance for Industry to evaluate cardiovascular risk for new therapies to treat type 2 diabetes. FREEDOM-CVO evaluated the safety of ITCA 650 at 60 micrograms per day vs. placebo in just over 4,000 patients on a variety of approved standard of care anti-diabetes therapies. The duration of study was dependent on event-based outcomes, and lasted just under 3 years, reaching the target number of cardiovascular events in the fourth quarter of 2015. The average treatment duration in FREEDOM-CVO was 1.2 years. Age eligibility for the study was 40 years and older. Inclusion criteria stipulated patients must have HbA1c > 6.5%, a history of coronary, cerebrovascular or peripheral artery disease, or multiple CV risk factors. The primary objective was to conduct a meta-analysis across FREEDOM-CVO and other phase 3 studies to demonstrate that the upper limit of the 95% confidence interval of the hazard ratio of major adverse cardiac events (MACE) in adult patients on Standard of Care for type 2 diabetes receiving either ITCA 650 or placebo, does not exceed 1.8. There were a total of 160 strict MACE events observed in the FREEDOM-CVO trial. The overall safety and tolerability data for ITCA 650 was consistent with the three phase 3 trials that have already been presented and what is documented in the published literature for exenatide and other GLP-1 receptor agonist therapies.
Additional Studies Planned Pre and Post-Approval
"Pre-approval CV safety trials like ours are smaller in size, shorter in duration, and designed very differently from the much larger and longer-duration trials that the FDA requires to assess CV safety or the potential for CV benefit in a post-approval setting,"explained Kurt Graves. "Due to recent emerging evidence from larger and longer-duration treatment trials showing GLP-1 receptor agonist therapies may provide CV benefit, Intarcia will consider the best way to evaluate the potential magnitude of CV benefit possible with ITCA 650 going forward. Our once or twice-yearly dosing and the built-in adherence aspects of our novel therapy could be very important to document in this chronic therapy setting."
Intarcia is also preparing to conduct additional head-to-head superiority studies against market-leading oral and injectable medicines. Some of the comparative trials will start this year, while other trials are planned to start with payers after approval to evaluate the relative performance of ITCA 650 vs. other type 2 diabetes therapies in ‘real-world’ settings where poor adherence and poor control with pills and self-injections are best assessed. “In addition to clinical trial data, payers really want to see high quality ‘real-world’ outcomes data because real world effectiveness and performance over time is what payers really care about and what they should really want to pay for,” said Graves.
About ITCA 650
ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia’s proprietary technology platform, a matchstick-size, miniature osmotic pump that is placed sub-dermally to provide continuous and consistent drug therapy, and the company’s proprietary formulation technology, which maintains stability of therapeutic peptides above human body temperature for extended periods of time. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist that is currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. When approved, ITCA 650 will be the first injection-free GLP-1 therapy that can deliver up to a full year of treatment from a single placement of the osmotic mini-pump. ITCA 650 is currently being evaluated in the FREEDOM global Phase 3 clinical trial program. All four FREEDOM trials have been successfully completed. FREEDOM-2 demonstrated head-to-head superiority in glucose control after 52 weeks over the market-leading oral therapy, Januvia® (sitagliptin). The fourth and last of the FREEDOM clinical trials, the FREEDOM-CVO trial, began close-out procedures in 4Q15 after reaching the target number of major cardiovascular events. The FREEDOM-CVO trial now has met its primary and secondary endpoints and succeeded in delivering the clinical results necessary for regulatory filings.
About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. In addition, delivering medicines just once or twice-yearly has the potential to ensure improved patient adherence and compliance, which is very poor in most chronic diseases. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above-body temperature and to deliver them in a continuous and consistent manner via Intarcia's proprietary technology platform. Intarcia has successfully completed its FREEDOM Phase 3-stage development program for type 2 diabetes, which consisted of four separate clinical trials. Intarcia continues to conduct research and development, utilizing its platform technology, to treat other chronic serious disorders in the field of diabetes and obesity. For more information on the Company, please visit www.intarcia.com.
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc.
(510) 782-7800 (office)
(973) 800-2530 (mobile)