TYPE 1 DIABETES

A Lifelong and Rising Global Burden
T1D is a chronic autoimmune disease affecting an estimated 8–9 million people worldwide, with incidence continuing to rise, particularly among children and adolescents. Despite major advances in glucose monitoring, insulin formulations, and delivery technologies, the standard of care still relies on lifelong insulin replacement therapy, which manages symptoms but does not address the underlying autoimmune destruction of pancreatic beta cells.
T1D imposes a substantial and enduring burden on patients, healthcare systems, and society. Individuals must continuously manage blood glucose levels to avoid acute complications such as hypoglycaemia and diabetic ketoacidosis, as well as long-term risks including cardiovascular disease, neuropathy, nephropathy, and retinopathy. The condition requires constant monitoring, intensive daily management with injected insulin and specialised medical care, resulting in significant healthcare costs and a profound impact on quality of life. As global incidence continues to increase, particularly in younger populations, there is a growing need for innovative approaches that improve real-time glucose control beyond insulin replacement alone, creating an opportunity for dual-hormone therapies incorporating both insulin and glucagon
Dual-Hormone Artificial Pancreas: Promise and Formulation Challenges
Over the past two decades, insulin pump therapy combined with continuous glucose monitoring (CGM) has significantly improved the management of T1D. Hybrid closed-loop systems are now capable of automatically adjusting insulin delivery based on real-time glucose measurements, leading to better glycaemic control and a reduced risk of severe hypoglycaemia compared with traditional multiple daily injections. These technologies have eased part of the daily burden of disease management and improved quality of life for many patients. However, insulin-only systems still have limitations, particularly in their ability to rapidly correct hypoglycaemia, often requiring patient intervention through carbohydrate intake or manual adjustments.
Dual-hormone artificial pancreas systems (combining insulin with glucagon) represent one of the most promising advances toward fully automated glucose control in T1D. By delivering small, controlled doses of glucagon to prevent or correct hypoglycaemia, these systems have the potential to more closely replicate the body’s natural glucose regulation and significantly reduce the daily burden of disease management for patients. However, the widespread development and deployment of such systems has been constrained by a major pharmaceutical challenge: the difficulty of obtaining stable, soluble glucagon formulations suitable for continuous pump delivery. Native glucagon is inherently unstable in aqueous solution, rapidly forming aggregates and fibrils that compromise both potency and device compatibility. As a result, the development of glucagon analogues or prodrugs capable of maintaining high solubility and stability in pump reservoirs remains a critical enabling step toward fully reliable artificial pancreas systems.

Kapiglucagon: A Next-Generation Glucagon Prodrug Designed for Stability

Kapiglucagon has been developed to address the key pharmaceutical limitations associated with native glucagon. It is a water-soluble glucagon prodrug designed to maintain high stability in aqueous solution while regenerating native glucagon in vivo following subcutaneous administration. Unlike native glucagon, which rapidly aggregates and forms fibrils in solution, Kapiglucagon demonstrates excellent solubility and formulation stability, enabling the development of clean, saline-based formulations that do nor clog pump-based delivery systems. This improved physicochemical profile makes Kapiglucagon particularly well suited for continuous or intermittent delivery in advanced diabetes technologies, including next-generation artificial pancreas systems. By combining the therapeutic activity of native glucagon with a formulation that overcomes its inherent instability, Kapiglucagon has the potential to provide more reliable and practical dual-hormone automated glucose control solutions for patients with T1D and avoid the long-term health complications of inadequate blood glucose control.
Our Vision
ImmuPharma’s vision is to position Kapiglucagon as a key enabling solution for next-generation artificial pancreas technologies. By overcoming the long-standing instability of native glucagon in aqueous formulations, Kapiglucagon offers the potential to deliver a stable, pump-compatible glucagon source, allowing dual-hormone closed-loop systems to operate safely and effectively. Through this innovation, ImmuPharma aims to contribute to a new generation of diabetes care in which artificial pancreas systems can significantly reduce the daily burden of disease while improving metabolic control and patient quality of life.
