US-based Intarcia Therapeutics has reported positive cardiovascular safety results from Phase lll FREEDOM-CVO trial of ITCA 650, an investigational therapy for type 2 diabetes.
Currently under development, ITCA 650 contains exenatide, which is a glucagon-like peptide-1 (GLP-1) receptor agonist that is now marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes.
The FREEDOM-CVO safety trial is the fourth and final Phase lll clinical trial of the FREEDOM programme that started in 2013.
FREEDOM-CVO was conducted on more than 4,000 patients and met its primary and secondary endpoints by demonstrating FDA required non-inferiority for pre-approval cardiovascular (CV) safety.
The primary objective was to conduct a meta-analysis across FREEDOM-CVO and other Phase lll 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.
A total of 160 strict MACE events were observed in the FREEDOM-CVO trial.
The overall safety and tolerability data for ITCA 650 were consistent with the three Phase lll trials that have already been presented.
Intarcia Therapeutics diabetes chief medical officer Dr Michelle Baron said: "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 lll trials required for the regulatory submissions for ITCA 650.
"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."
The company also announced a $75m 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.
Intarcia is also planning to conduct more head-to-head superiority studies against several other oral and injectable medicines, with expectation to start some of the comparative trials this year.
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 assessed.