Dezima Pharma has announced that it has received very positive results in its Phase 2b TULIP clinical trial, a double blind, placebo controlled, Phase 2b dose ranging study of TA-8995 (DEZ-001), as monotherapy and in combination with statins for treating dyslipidemia.
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.
“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, CEO of Dezima pharma. “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 3.”
John Kastelein, CSO and co-founder of Dezima 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(a), compatible with very significant reductions of cardiovascular risk.”
Two members of Dezima’s Scientific Advisory Board, both world-leading experts in the dyslipidemia field, also commented on the results: “The TULIP study met all its predefined primary endpoints both for efficacy and safety with impressive reductions of all atherogenic lipoproteins which therefore justifies the initiation of a Phase 3 mortality and morbidity outcome trial”, commented Bryan Brewer, MD, Director at Washington Cardiovascular Associates, Washington DC, USA.
Philip Barter, MD, Professor at the Center of Vascular Research, University New South Wales, Sydney, Australia added: “In the TULIP study TA-8995, in combination with statin therapy, achieved reductions of LDL-C that are close to reductions achieved by the PCSK9 inhibitor class. Moreover TA-8995 achieved these results without any apparent sign of accumulation of the compound.”
The company plans to publish the full data over the coming months in peer reviewed journals. Meanwhile Dezima will continue to collect data from its ongoing studies (DDI, TQT and a pilot study on Lp(a)), while preparing for the start of pivotal Phase 3 studies in 2015.