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Karo Bio Announces Sucessfule Phase II Results of KB2115

HUDDINGE, Sweden,11-Jun-2007 / Karo Bio (STO:KARO) successful KB2115 Phase II study meets primary objectives. The 12 week proof of concept phase II study with KB2115 in patients with dyslipidemia has been successfully completed. KB2115 is efficacious in LDL lowering and safe with respect to a broad range of parameters reflecting effects on heart, bone, muscle and thyroid function.

The thyroid hormone receptor (TR) is a key regulator of metabolic pathways and holds the promise of a new target for the treatment of dyslipidemia. KB2115 is an innovative and first in class liver selective agonist for the TR. Unlike the natural thyroid hormones, KB2115 is a liver selective TR agonist that can induce pharmacological effects in the liver, while a normal thyroid state is preserved in the rest of the body.

The completed 12 week, placebo controlled, double blind, randomised, clinical phase II study in 99 patients with high cholesterol levels was designed to explore whether a clinically relevant LDL-cholesterol lowering effect can be achieved without affecting the heart, bone, muscle and thyroid function.

The study demonstrated that a pronounced and clinically relevant lowering of LDL cholesterol can be obtained while preserving the thyroid homeostasis outside the liver and biomarkers for heart, bone, muscle and other organs were kept at normal levels. The mild increase in liver enzymes that was picked up in the previous 2-week phase I trial, was observed in this study as well, however, it seems to be a transient and benign effect. In addition to the positive result regarding efficacy and safety it was also shown that the enteric coating of KB2115 was effective in protecting the compound from chemical modification in the stomach.Thereby, a safety concern for longer exposure in man is removed.

The specific results from the KB2115 phase II study will be presented at upcoming international conferences dur
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