KARO BIO HAS INITIATED CLINICAL TRIALS WITH KB3305

The anti-diabetic compound KB3305 has now entered phase I clinical studies. Single ascending doses as well as multiple ascending doses will be given to healthy volunteers as well as to type 2 diabetes patients, to evaluate safety, tolerability and pharmacodynamic parameters such as fasting and postprandial blood glucose lowering efficacy. The entire phase I program will include about 110 subjects.

For type 2 diabetics it is important to maintain strict glycemic control in order to avoid microvascular complications, which are associated with the disease long term. Oral therapies are the basis for managing good glucose control, with addition of insulin as needed. Despite recent additional therapeutic options, the need for new drugs with an improved therapeutic window remains.

It is well known that fasting blood glucose levels are elevated in type 2 diabetic patients due to excessive hepatic glucose production. KB3305 is a liver targeted glucocorticoid antagonist that suppresses hepatic glucose production, resulting in decreased fasting blood glucose levels. This novel mechanism of action for improvement of glycemic control has been developed in collaboration with Professor Suad Efendíc, Karolinska Institutet, and can become an important contribution to the treatment of type 2 diabetes. 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.

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.

“Our prioritized projects are progressing according to plan and one of the important goals for this year has now been reached. 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”, says Per Olof Wallström, President of Karo Bio.



For further information, please contact:
Per Olof Wallström, President & Chief Executive Officer
Telephone: +46 8 608 60 20

Per Otteskog, Senior Vice President
Telephone: +46 8 608 60 18


Facts about Karo Bio
Karo Bio is a drug discovery and development company specializing in nuclear receptors for the development of novel pharmaceuticals with focus on metabolic diseases.

The company has expanded from being a drug discovery company by adding in-house preclinical and clinical development resources and competence for development of drugs to treat metabolic diseases. The company has a strong project portfolio with innovative molecules that primarily targets diseases such as diabetes, atherosclerosis and dyslipidemia. In all of these areas there are significant market opportunities and a growing need for new pharmaceuticals with new mechanisms of action.

In addition to the proprietary projects Karo Bio has two strategic collaborations with international pharmaceutical companies and one biotech collaboration for development of innovative therapies for the treatment of common diseases.

Karo Bio is listed on the OMX Nordic Exchange Stockholm AB since 1998 (Reuters: KARO.ST). This press release is also available online at: www.karobio.se and www.newsroom.cision.com