Monday 30 March 2009

Karo Bio drug cuts cholesterol on top of statins

By Lewis Krauskopf


ORLANDO, Fla., March 29 (Reuters) - Patients taking statin cholesterol-lowering drugs cut their bad LDL cholesterol levels as much 32 percent more when they added an experimental medicine from Karo Bio AB (KARO.ST), according to mid-stage study results released on Sunday.


The drug, eprotirome, also cut triglycerides 15 percent to 33 percent, according to results presented at the American College of Cardiology (ACC) scientific meeting in Orlando. The company had previously said the trial was successful, but did not release specifics.


The results suggest eprotirome has the potential to open a new avenue for treating heart disease, according to a press statement released by the ACC. Eprotirome is designed to target thyroid hormones receptors in the liver that regulate cholesterol.


"This study provides hope for a new add-on treatment of dyslipidemia for patients who are inadequately controlled with, or intolerant to, current lipid-lowering therapy," said Jens Kristensen, Karo's vice president of clinical development.


The 12-week study followed 189 patients who had high cholesterol despite already taking low to moderate doses of two other statins, Merck's (MRK.N) Zocor and Pfizer's (PFE.N) Lipitor. Patients were randomly assigned to one of three doses of eprotirome or a placebo.


Patients on eprotirome cut their LDL cholesterol by 21 percent to 32 percent. Subjects on the placebo cut their LDL 6 percent, as they were likely more compliant with their statin drugs while in the clinical study, according to the company.


There were no observed changes in heart rate or cardiac rhythm and the drug was well-tolerated, the ACC statement said.


Sweden's Karo said the next step will be to confirm the results in a pivotal Phase III study.


Karo said last August the Phase IIb study was successful in lowering LDL and triglycerides, but did not release detailed results at the time. Nonetheless, Karo shares soared on the news.


The company has said it plans to find a partner to help advance eprotirome to the market. (Editing by Maureen Bavdek)