Liver-selective antagonist for glucocorticoid receptors
Large medical need
No less than 220 million people worldwide suffer from diabetes, a figure expected to rise to 366 million by 2030. Of them, 90 percent have type 2 diabetes. Sales of drugs for the treatment of type 2 diabetes are expected to double from about USD 19 billion in 2009.
Several drugs stimulate the body's regulation of insulin while others act directly or indirectly on insulin metabolism or homeostasis. Despite the large number of available drugs, many patients do not reach their treatment goals for blood sugar level. Hence, there is a need for drugs with new functions. KB3305 focuses primarily on reducing glucose production in the liver, which none of the current treatments do.
Product profile
KB3305 is a liver-selective GR antagonist. The compound has been developed for the treatment of type 2 diabetes and is the first of its kind to be tested on humans. In preclinical trials, KB3305 has proven to be both safe and efficacious. Karo Bio demonstrated in a clinical phase I/IIa study reported in 2009, that blood sugar levels can be lowered by blocking GR activity in the liver. These data provide a positive proof-of-principle for the mechanism of action, and the effects are large enough to be considered medically relevant for the treatment of patients with type 2 diabetes.
In addition to better control of glucose levels, preclinical studies indicate that KB3305 also lowers a number of other risk factors for type 2 diabetes, such as LDL cholesterol, triglycerides and free fatty acids in plasma.
Development status
Before further clinical studies are carried out, Karo Bio believes that a new formulation and a new production process must be developed. Regulatory requirements on the magnitude of the studies required for approval for type 2 diabetes have risen dramatically in recent years, meanwhile that the competition is great. Karo Bio is therefore investigating other potential indications for KB3305 while evaluating the possibility of developing a new compound that utilizes the clinical proof-of-principle that has been demonstrated.
