Strong Ph IIb results with Dezima’s CETP inhibitor TA-8995 in dyslipidemia

Privately-held Dutch biotech firm Dezima Pharma says it has received very positive results in its Phase IIb TULIP clinical trial, a double blind, placebo controlled, Phase IIb dose ranging study of TA-8995 (DEZ-001), as monotherapy and in combination with statins for treating dyslipidemia (high cholesterol).

Dezima acquired rights to TA-8995 (DEZ-001) from Japanese drug major Mitsubishi Tanabe Pharma (TYO: 4508) early last year (The Pharma Letter January 22, 2013).

The TULIP (TA-8995: its Use in patients with mild dysLIPidemia) study was conducted in specialized cardiovascular centres across Denmark and the Netherlands. A total of 364 patients were randomized into nine cohorts; a placebo, TA-8995 alone at different doses, or in combination with different statins. The study investigated the effects of TA-8995 on a wide range of established cardiovascular disease (CVD) biomarkers over a three months' dosing period.

The results 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(a) (Lp(a)). There were no safety or tolerability issues identified or any pharmacokinetic concerns about potential accumulation of the drug.

Will move into Ph III testing

"These results are clearly very exciting. Compared to other CETP inhibitors TA-8995 combines the highest levels of efficacy seen on lipid parameters with a 20-fold lower dose," stated Rob de Ree, chief executive of Dezima Pharma, adding: "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."

John Kastelein, chief scientific officer and co-founder of Dezima, commented: "The results emphasize that TA-8995 robustly lowers all atherogenic lipoproteins, LDL-C, the entity of non HDL-C, apoB as well as Lp(a), compatible with very significant reductions of cardiovascular risk.