KARO BIO HAS PRESENTED POSITIVE KB2115 PHASE II DATA AT TWO INTERNATIONAL SCIENTIFIC CONGRESSES

Positive Phase II data has been obtained with KB2115. Treatment of 98 patients showed that KB2115 produced clinically relevant lowering of several risk factors associated with development of cardiovascular disease. KB2115 was also well tolerated. Key scientific data were disclosed at the DALM (Drugs Affecting Lipid Metabolism) congress, on October 5, and at the 78th Annual Meeting of the American Thyroid Association, on October 6, both in New York City.

KB2115 is a first in class, liver and receptor selective thyroid hormone receptor agonist, intended for the treatment of dyslipidemia. Karo Bio presented the first clinical phase II data demonstrating that profound blood lipid lowering may be achieved while avoiding cardiac and other side effects typically associated with non–selective thyromimetics.

A 12–week, placebo controlled, double blind, randomised phase IIa study was designed to explore whether clinically relevant LDL-cholesterol lowering can be achieved without adversely affecting the heart, bone, muscle and thyroid function. KB2115 induced a pronounced and statistically significant lowering of LDL-cholesterol (-23% and -29% at 100 µg and 200 µg daily dosing, respectively). An improved Apo B/Apo A-1 ratio (a risk factor which strongly correlates with myocardial infarction) was also observed. Triglycerides were significantly reduced; averaging 38% at the 200 µg dose level and even more profoundly in subjects with elevated levels. Further, the independent risk factor lipoprotein (a), which correlates with the development of cardiovascular disease, was lowered by up to 45% at the highest dose. While HDL remained unchanged in this study, data from a previous clinical study suggests that KB2115 promotes reverse cholesterol transport.

Thyroid hormone homeostasis in extra–hepatic tissues was preserved, i. e. the levels of TSH and T3 were preserved at normal levels. T4 levels were moderately decreased, but remained within normal levels. The heart, bone metabolism, and muscle parameters were unchanged. Transient, dose dependent effects on liver enzymes were noted, but considered to be benign. There were no consecutive ALT elevations above 3-fold Upper Limit of Normal and no concomitant increases in bilirubin levels.

“This study shows that KB2115 is a promising new agent for dyslipidemia. We have in this study evaluated the safety and efficacy of KB2115 monotherapy in the higher dose interval, and will now continue to investigate the effects of lower doses of KB2115 given concomitantly with statins. We are very encouraged by these positive results with KB2115, and excited about the continuation of its development”, says Per Olof Wallström, President of Karo Bio.



The dyslipidemia market is the largest pharmaceutical market segment in the world with sales around $ 30 billion. High LDL cholesterol levels are strongly associated with the risk for cardiovascular disease. The market trend is to more efficiently lower LDL cholesterol levels and larger doses of statins as well as combination therapies are being introduced. New drugs with a new mechanism of action, like KB2115, that can be used alone or in combination with statins are required to reach treatment targets.



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 och www.newsroom.cision.com