Karo Bio has initiated a second clinical phase IIb dose ranging study with eprotirome. This study would be conducted in dyslipidemia patients receiving concomitant treatment with the cholesterol absorption inhibitor ezetimibe.
The first phase IIb study in 180 patients where eprotirome is given in addition to statin treatment is progressing according to plan.
Karo Bio's compound eprotirome is a novel, selective, thyroid hormone agonist for treatment of dyslipidemia. In a first phase IIa study, eprotirome induced a significant LDL-cholesterol lowering of 25-30 per cent in dyslipidemia patients. Furthermore, eprotirome significantly reduced other risk factors for development of cardiovascular disease such as triglycerides and lipoprotein, and was well tolerated.
Eprotirome has a promising profile for treatment of dyslipidemia, either alone or in combination with other dyslipidemia drugs. 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.
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. Ezetimibe is a well documented cholesterol absorption inhibitor and thus complements eprotirome well with a different mechanism of action. 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 100 µg in addition to 10 mg per day of ezetimibe. The results of the study are expected in the fourth quarter of 2008.
"Eprotirome has potential to become a major drug in the treatment of high blood lipids. The broad and unique efficacy profile affecting several independent risk factors for the development of cardiovascular disease, in combination with good tolerability and safety, makes eprotirome a very attractive therapeutic option, either as a single agent or in combination with statins or ezetimibe. With this phase II programme we are positioning eprotirome for partnership negotiations and phase III clinical studies", said Per Olof Wallström, president, Karo Bio.
Elevated blood lipids (dyslipidemia) significantly correlate with development of cardiovascular disease. In particular high plasma levels of the harmful LDL-cholesterol contribute to disease development. Statins are an effective class of drugs that is widely used for treatment of dyslipidemia. Still, there is a great need for new dyslipidemia drugs that can be used together with statins since a significant part of the patients do not reach the treatment goals on single therapy or are intolerant to or unresponsive to statin treatment. The trend is therefore to combine statin treatment with other pharmaceuticals in order to reach desirable effects / combinations with cholesterol absorption inhibitors, like ezetimibe, have been successful but there is still a great need for new treatment options.
The total dyslipidemia market has annual sales around US $30 billion, whereof the statin class of drugs account for US $25 billion.