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news.Dutch biotechnology firm Dezima Pharma has reported positive results from its Phase IIb TULIP clinical trial of TA-8995 (DEZ-001), as monotherapy and in combination with statins to for treating dyslipidemia.
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The double blind, placebo controlled Phase IIb dose ranging trial was conducted in specialized cardiovascular centres across Denmark and the Netherlands.
In the trial, a total of 364 patients were randomized into nine groups; a placebo, TA-8995 alone at different doses, or in combination with different statins.
The trial evaluated the effects of TA-8995 on a wide range of established cardiovascular disease (CVD) biomarkers over a three months’ dosing period.
Results from the trial showed dramatic effects on the primary endpoint, which was a composite of changes in lowering LDL-C and raising HDL-C, as well as strong and clinically relevant effects on other parameters including cholesterol efflux and Lipoprotein.
The company said that there were no safety or tolerability issues identified or any pharmacokinetic concerns about potential accumulation of the drug.
Dezima pharma CEO Rob de Ree said compared to other CETP inhibitors TA-8995 combines the highest levels of efficacy seen on lipid parameters with a 20-fold lower dose.
"Combined with the excellent safety and favorable pharmacokinetic profile this positions TA-8995 as the best-in-class CETP inhibitor as we move towards Phase III," de Ree said.
Dezima CSO and co-founder John Kastelein said, "The results emphasize that TA-8995 robustly lowers all atherogenic lipoproteins, LDL-C, the entity of non HDL-C, apoB as well as Lp, compatible with very significant reductions of cardiovascular risk."