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news.Karo Bio has started the second clinical Phase IIb dose ranging study with eprotirome. This study will be conducted in dyslipidemia patients receiving concomitant treatment with the cholesterol absorption inhibitor ezetimibe.
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The intention with the new Phase IIb dose ranging study is to expand the clinical and commercial potential for eprotirome in dyslipidemia treatment by exploring whether eprotirome in combination with ezetimibe can serve as an alternative to statin treatment. The study is a placebo controlled, parallel group, double blind, 10 week study dose ranging study in 100 patients. Eprotirome is given once daily in doses of 25, 50, or 100µg in addition to 10mg per day of ezetimibe. The results of the study are expected in the fourth quarter of 2008.
Karo Bio’s compound eprotirome is a novel, selective, thyroid hormone agonist for treatment of dyslipidemia. Currently eprotirome is given in addition to simvastatin or atorvastatin in the first Phase IIb dose ranging study in 180 patients. This study is progressing according to plan and the results will be available in the third quarter of 2008.
Per Olof Wallström, president of Karo Bio, said: “Eprotirome has potential to become a major drug in the treatment of high blood lipids. With this Phase II program we are positioning eprotirome for partnership negotiations and Phase III clinical studies.”