The Phase I program will start with single and multiple ascending doses given to healthy volunteers. The last part of the program will include multiple doses given to patients with type 2 diabetes.
This will ensure preliminary data on efficacy and safety in the target population. In total, about 110 healthy volunteers and patients will be included in the planned Phase I studies.
KB3305 is a liver targeted glucocorticoid antagonist that suppresses hepatic glucose production, resulting in decreased fasting blood glucose levels. In preclinical pharmacodynamic and toxicity studies, KB3305 was shown to be both efficacious and safe. In addition, KB3305 displayed preclinically a highly competitive potential with beneficial effects on both triglyceride and free fatty acids levels in plasma.
Per Olof Wallström, president of Karo Bio, said: “We are optimistic about the Phase I program that apart from safety evaluations also will give us important information about the effect of KB3305 in patients.”