October 31, 2008
Karo Bio Completes Phase II Dyslipidemia Trial
Karo Bio, a drug discovery and development company, has successfully completed a 10-week Phase IIb study with eprotirome given to dyslipidemia patients undergoing treatment with the cholesterol absorption inhibitor ezetimibe.
Eprotirome induced a statistically significant and clinically relevant lowering of serum low-density lipoprotein (LDL)-cholesterol, triglycerides and lipoprotein(a) and was safe and well tolerated. Data show that eprotirome in combination with ezetimibe can become an important treatment option for patients with dyslipidemia.The intention with the new Phase IIb dose ranging study was 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 was a placebo controlled, parallel group, double blind, 10-week dose ranging study in 109 patients. Eprotirome was given once daily in doses of 25, 50, or 100mcg in patients who were on a stable ezetimibe treatment, of 10mg per day.
Top line data show that there was a statistically significant lowering of LDL-cholesterol in the range of 15-25% on top of ezetimibe treatment, which is in line with previous monotherapy and statin combination studies. Pronounced and clinically relevant reductions of triglycerides and lipoprotein(a) were also documented.
Per Wallstrom, president of Karo Bio, said: "We have, in three consecutive Phase II studies, treated a total of 391 patients with eprotirome. The data are consistent and robust across the three studies. Firstly, the compound has been well tolerated. With these Phase II results we have built up a strong position for partner discussions and upcoming Phase III studies."