Karo Bio reports positive results for new glucose control compound for diabetes

8 April 2009

Karo Bio’s (STO:KARO) compound KB3305, a liver selective antagonist for the glucocorticoid receptor, shows clinically relevant and statistically significant effects on plasma glucose levels in type 2 diabetes patients.

Karo Bio has concluded a clinical phase I program with the anti-diabetes compound KB3305. The program consists of three parts. The first part, where KB3305 was successfully given as increasing single doses to healthy volunteers, was reported in April 2008.

Karo Bio has now completed the second and third parts which involved repeated dosing to healthy volunteers and repeated dosing in a group of type 2 diabetes patients, respectively.

In the second part of the phase I program, 24 healthy volunteers were treated with KB3305 at doses up to 450 mg per day for a period of five days. Tolerability and safety were satisfactory, and no serious adverse events were recorded. The pharmacokinetic profile of the compound was robust and predictable.

In the third part of the program, 14 patients with type 2 diabetes were treated with up to 450 mg KB3305 per day over a period of 14 days. A control group was given the corresponding placebo. The allocation to each treatment group was randomized and blinded. Since KB3305 is a first in class compound, the purpose of this study was to establish proof of principle, ie to investigate if KB3305 has clinically relevant effects on fasting plasma glucose levels in diabetes patients.

The results show a pronounced, clinically relevant, and statistically significant lowering of fasting plasma glucose levels (compared to baseline as well as against placebo) and also a statistically significant improvement in glucose tolerance tests. The side-effect profile was acceptable, and no serious adverse events were recorded.

Before initiation of phase II clinical trials, Karo Bio will evaluate all existing data and make a decision regarding the need for further optimization of the pharmaceutical formulation.

“KB3305 is a first in class compound, and with these results Karo Bio confirms its capability to develop innovative and efficacious treatment principles. The clinical results are consistent and pronounced, and offer an excellent basis for further clinical development”, says Per Olof Wallström, President of Karo Bio.

Bookmark this page

To top