CLINICAL STUDIES FOR KB2115 INITIATED

Karo Bio has initiated Phase I clinical studies for KB2115 which is a compound with promising properties for treatment of obesity and dyslipidemia. The primary goal with the study is to evaluate tolerability, safety and pharmacokinetics as well as effects on high blood lipids and other cardiovascular risk factors.

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 need for new pharmaceuticals for treatment of overweight subjects with dyslipidemia is therefore considerable.
Karo Bio has through a number of animal studies shown that KB2115 increases the body’s energy consumption and reduces body weight and markedly reduces blood lipids and blood glucose. KB2115 works by selectively 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. The background to the promising features of KB2115 is that the compound has receptor and tissue selective properties and thereby negative effects on the heart can be avoided.
KB2115 has been judged to be safe in a previous Phase I study in humans and Karo Bio now continues the clinical programme with a randomized, double-blind, placebo-controlled Phase I study in healthy, but overweight males/females with elevated blood lipids. The primary objective in the new Phase I study is to determine the short term safety and tolerability of single (Phase Ia) and multiple oral doses of KB2115 administered daily over a 14 day period (Phase Ib). In addition to safety and tolerability, effects of KB2115 on blood lipids and metabolic markers will be measured. The Phase Ia single dose part of the study covers 24 subjects and dosing of these have now been initiated. This study will, after evaluation, be followed up with the Phase Ib multi dose study which covers another 24 subjects.
“We are excited about the continued clinical development of KB2115”, says Per Olof Wallström, President of Karo Bio. “The compound has a unique profile and a great potential and it is our intention to develop it into a medicine for specific patient groups.”

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

Facts about Karo Bio
Karo Bio has operations in Huddinge, Sweden, and 76 employees.
Karo Bio has been listed on the Stockholm stock exchange (Reuters: KARO.ST) since 1998 and maintains a leading position in the field of drug discovery focused on nuclear receptors. Nuclear receptors are validated drug targets for a number of clinical indications and the Company uses proprietary technologies for the development of novel and improved therapies for major markets.
Karo Bio has drug discovery programs in several therapeutic areas including women’s health care, cancer, cardiovascular disease, atherosclerosis and diabetes.
Karo Bio collaborates with major pharmaceutical companies for the development of products and marketing. In these collaborations Karo Bio receives upfront payments, R&D funding and milestone payments, as well as royalties on net sales when products reach the market.
Karo Bio has strategic pharmaceutical drug discovery collaborations with Merck & Co., Inc. and Wyeth Pharmaceuticals.

This press release is also available online at www.karobio.com and at www.waymaker.net.