KARO BIO GETS APPROVAL FOR CLINICAL STUDIES WITH KB2115

The Swedish Medical products Agency has approved Karo Bio’s application for start of a clinical phase I b study with the clinical candidate KB2115 on overweight subjects with dyslipidemia. The primary goal with the study is to evaluate tolerability and safety and pharmacokinetics as well as effect on important risk factors for cardiovascular disease.

Overweight constitutes a serious health problem and is highly related to dyslipidemia and hyperglycemia. As a consequence there is an increased risk for development of cardiovascular disease and diabetes. The problem is increasing in the Western World and is appearing in younger individuals. The need for new pharmaceuticals for treatment of overweight subjects with dyslipidemia is therefore considerable. Karo Bio has through a number of animal studies showed that KB2115 increases the body’s energy consumption and reduce body weight and markedly reduces blood lipids and blood glucose. KB2115 works by stimulating the thyroid hormone receptor which is the protein in the body that mediates the effects of thyroid hormone. Natural thyroid hormone cannot be used for the same purpose due to the risk of adverse effects on the heart. Karo Bio’s extensive safety documentation shows that KB2115 does not generate these adverse effects. In addition, KB2115 has been judged to be safe in a phase I a study in humans. The background to the promising features of KB2115 is that the compound is tailor-made to selectively act through the thyroid hormone receptor beta instead of the alpha receptor that produces negative effects on the heart. “KB2115 is a very potent compound with a unique and promising profile for treatment of both obesity and dyslipidemia” says Per-Olof Wallström, president of Karo Bio. “This exemplifies the strategic shift of Karo Bio since we from now on take responsibility for clinical development of our compounds up to clinical data on patients in phase 2”. KARO BIO AB For further information, please contact: Per Olof Wallström, President &Chief Executive Officer Telephone: +46 8 608 60 20 Dr. Per Otteskog, Senior Vice President Telephone: +46 8 608 6018