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news.Swedish drug development company Karo Bio has received approval for initiation of a Phase IIb clinical study with KB2115, a novel, selective, thyroid hormone agonist for treatment of dyslipidemia.
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The Phase IIb study is a placebo-controlled, parallel-group, double-blind randomized 12-week study in 172 patients. The study contains four arms with 43 patients per arm. KB2115 will be given in doses of 25, 50 and 100 micrograms to dyslipidemia patients on top of statin treatment.
A corresponding placebo control receiving statin only will constitute the fourth treatment group. The results from the study are planned to be presented in third quarter of 2008.
In the first Phase IIa study, the compound KB2115 was found to be efficacious and safe given as 100 or 200 micrograms as monotherapy to dyslipidemic patients. Furthermore, KB2115 has significant effects on other risk factors for development of cardiovascular disease such as triglycerides and lipoprotein.
Per Olof Wallström, president of Karo Bio, said: “The KB2115 development is progressing in accordance with our previously communicated plan. The results obtained to date regarding efficacy, clinical safety and tolerability are very encouraging as we are continuing clinical development.”