Karo Bio Announces Successful Phase II Study with Eprotirome in Combination with Statin

05-Aug-2008

Karo Bio has successfully completed a 12 week phase IIb study of eprotirome (KB2115) given to patients with dyslipidemia (elevated blood lipids). These patients were already on statin treatment. Data show that eprotirome induced a statistically significant and clinically relevant lowering of serum LDL-cholesterol, triglycerides and lipoprotein (a) and was safe and well tolerated. The data indicate that eprotirome has the potential to become an important new medicine for treatment of dyslipidemia.

Eprotirome is a novel, selective, thyroid hormone receptor agonist, developed for treatment of dyslipidemia. To explore the potential for eprotirome as an add-on to standard statin treatment, Karo Bio conducted a phase IIb placebo controlled, randomized, double blind, 12 week study in 189 patients, each with high levels of serum cholesterol. Three different doses of eprotirome were tested on a background of statin treatment.

The results show that eprotirome, in a dose-dependent manner, significantly lowered LDL-cholesterol, triglycerides and lipoprotein(a) when added to statin. The additional reductions are clinically relevant and of the same magnitude as eprotirome given alone. Eprotirome was safe and well tolerated. Sensitive markers of the body's thyroid hormone status were unaffected by eprotirome.

According to the company, the profile of eprotirome is unique in producing simultaneous and powerful reductions of three independent risk factors for the development of atherosclerotic cardiovascular disease. This combined effect on LDL-cholesterol, triglycerides and lipoprotein(a) indicates that eprotirome has the potential for being an important drug for dyslipidemia. Scientific data from the study will be presented at upcoming conferences during the fall of 2008.

"The study shows that eprotirome can be given safely with statins, and has significant therapeutic efficacy on LDL-cholesterol, triglycerides and lipoprotein(a) over and above the effect of statin. The unique clinical efficacy, tolerability and safety make this combination a potentially attractive therapy for patients who cannot achieve their treatment goals with statin alone. Karo Bio will proceed with its communicated strategy with the aim to develop eprotirome through phase III with a partner" says Per Olof Wallström, President of Karo Bio.

https://www.bionity.com/en/news/85400/karo-bio-announces-successful-phase-ii-study-with-eprotirome-in-combination-with-statin.html