Karo Bio reports positive results from diabetes study

Karo Bio, a drug discovery and development company, has reported that compound KB3305, a liver selective antagonist for the glucocorticoid receptor, showed 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. 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 450mg 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, the company said.

In the third part of the program, 14 patients with type 2 diabetes were treated with up to 450mg 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.

According to the company, the results showed a pronounced, clinically relevant, and statistically significant lowering of fasting plasma glucose levels and also a statistically significant improvement in glucose tolerance tests. 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.

Per Wallstrom, president of Karo Bio, said: 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.