Arecor Therapeutics plc, a clinical stage biotech company developing superior therapeutics to reduce treatment burden and improve outcomes for people living with diabetes, obesity and other cardiometabolic diseases, has strengthened its patent protection for the company’s proprietary AT278 product, the only ultra-concentrated (500 U/mL) ultra-rapid acting insulin.
European patent grant
The European Patent Office (EPO) has granted a key patent protecting AT278, covering its use in automated insulin delivery (AID) systems. This not only strengthens AT278’s existing European protection but also extends the patent term to at least 2039.
United States patent grant
The U.S. Patent and Trademark Office (USPTO) has granted a separate patent protecting AT278 for use in AID systems. This adds to the growing portfolio of granted patents protecting AT278 in the U.S., where there remains significant unmet patient need for concentrated ultra-rapid-acting insulins that can catalyze the next generation of miniaturized, longer-wear and fully closed loop AID systems. This patent grant also extends the patent term to at least 2039.
Indian patent grant
The Indian Patent Office has also granted a patent offering broad protection for the novel composition of AT278 in India.
Arecor’s concentrated ultra-rapid acting insulins are protected by over 30 granted patents in major markets across a range of concentrations from 100U/mL to over 500U/mL.
Dr Jan Jezek, CSO of Arecor commented:
“These new patents further strengthen the already robust IP portfolio protection for our concentrated ultra-rapid-acting insulins, and the novel technology underpinning them. We are continuously expanding our IP coverage particularly in key geographies and are pleased to have additional strong patents across the U.S., Europe and India, and to specifically cover the use of our insulins in AID systems, where there remains significant unmet patient need that we can address.”
Patient need and commercial opportunity
There is a real and significant unmet patient need for concentrated, ultra-rapid acting insulins to enable the next generation of longer wear, fully automated and miniaturized AID systems. In the U.S. alone, approximately four million people with diabetes (PWD) require intensive insulin therapy (IIT) and are candidates for AID systems.
Although AID systems are recommended (American Diabetes Association 2026 Guidelines) as the preferred insulin delivery system for individuals with Type 1 and Type 2 diabetes, the U.S. AID market remains underpenetrated, with only ~40% of Type 1 and ~5% of Type 2 patients using an AID system.
This low adoption rate reflects the patient preference for smaller, longer wear insulin pumps that offer ease-of-use and improved outcomes. In response to this unmet need, the industry has entered a new era of AID innovation, and the large multi-billion-dollar market cap insulin pump companies are pursuing longer wear, miniaturised and fully closed loop AID systems. To achieve these ambitions, insulins with the profile of AT290 and AT278 are required, alongside pump company innovations.
In this environment, Arecor has identified three significant opportunities for its superior insulins:
In the U.S., approximately one million PWD require more than 100 units of insulin per day. As current AID systems use only 100 U/mL (U100) insulins, they are unable to achieve the standard of care of three-day wear time even when using the largest insulin pump cartridges available today. Accordingly, PWD who require more than 100 units of insulin per day have no three-day wear options available to them. Arecor’s insulins would make AID systems practical and accessible to this patient population.
Another one million PWD who currently use AID systems also seek longer wear time (seven days or more) and miniaturised pumps. These innovations are limited by the capacity of the insulin pump cartridges which can hold 1.6-3.0mL, or the equivalent of 160-300 units of U100 insulin. With only U100 approved for use in AID systems today, almost all Type 2s and greater than 50% of Type 1 diabetics cannot achieved 7-day wear time using the largest 3.0mL cartridge. With rising prevalence of obesity, expansion of AID use to type 2 diabetes and a trend towards smaller pumps/insulin cartridges the need for concentrated ultra-rapid insulin is increasing.
Arecor’s novel insulins may be the first to enable a full closed loop (FCL), automated AID system. Current systems require users to count their carbohydrates and announce meals. This adds to the burden and complexity of using AID systems. In response to patient demand, the industry is moving toward FCL systems; however, faster acting insulins are required to achieve this objective.
Arecor’s insulins are the only products in development that have the potential to enable next generation seven-day wear, miniaturized pumps and FCL AID systems, reducing burden and improving outcomes for PWD. This also represents a significant commercial opportunity, where patients with the highest unmet need for longer wear and miniaturised pumps, represent an approximately $3 billion insulin revenue opportunity in the U.S. alone, with additional upside potential outside of the U.S.
