Despite an array of available drugs for type 2 diabetes (T2D), a huge unmet need remains when it comes to patients’ compliance with treatment. Currently awaiting US Food and Drug Administration (FDA) approval, Intarcia Therapeutics’ ITCA 650 is addressing this very issue.
With the successful completion of Phase III clinical trials, ITCA 650 has put immense competitive pressure on marketed T2D drug classes, in particular the glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors. If approved, ITCA 650 is poised to steal considerable market share from both of these classes, allowing Intarcia to contend with the top market leaders in the T2D space.
ITCA 650 is a technology platform that involves the subcutaneous placement of a matchstick-like osmotic pump that continuously releases exenatide, a T2D drug belonging to the GLP-1 receptor agonist class. This provides glycemic control through the activation of glucagon receptors on pancreatic beta cells, causing a cascade of biochemical events that lead to insulin secretion.
In contrast to daily or weekly administered T2D drugs, treatment with ITCA 650 is initiated with a three month dose, followed by a consecutive six month maintenance dose of exenatide. ITCA 650 treatment requires less administration vigilance over time compared to currently marketed T2D drugs, resulting in the potential to enhance poor patient compliance and effectively gain considerable market share.
In addition to the conferred advantage in compliance, ITCA 650 boasts significantly superior reductions in glycated hemoglobin (A1C) and weight loss over the course of a year versus Merck’s DPP-4 inhibitor Januvia (sitagliptin), the highest selling non-insulin T2D drug on the market. ITCA 650 also completed Phase III cardiovascular (CV) studies in May 2016, which resulted in positive CV safety results. This paves the way for Intarcia’s new drug application (NDA) submission to the FDA in November 2016.
While awaiting the FDA’s decision, Intarcia is actively pursuing additional pipeline agents for its drug delivering technology, most notably an anti-HIV prophylactic therapy. This incentive was further fueled by a $140m investment from the Bill & Melinda Gates Foundation in December 2016.
In addition, in early January of this year, Intarcia announced that it will collaborate with the California Institute for Biomedical Research to develop a novel long-acting peptide to be used in combination with exenatide for T2D and obesity. This may eventually allow ITCA 650’s pump to be replaced after intervals exceeding six months.