Dezima Pharma has announced the approval of a phase 1 pilot study in subjects with isolated, elevated Lipoprotein(a) (Lp(a)), for which additional funding has been secured.
The aim of this new study is to investigate the Lp(a) lowering effects of TA-8995 (DEZ-001), a best-in-class CETP inhibitor, in 36 asymptomatic subjects with isolated, elevated Lp(a) levels. Lp(a) is an independent major risk factor for cardiovascular disease and aortic stenosis. In previous phase 1 studies in healthy volunteers with normal baseline Lp(a) levels, TA-8995 has shown a potent effect on Lp(a) plasma levels.
Dezima Pharma is currently in the process of completing a phase 3 enabling program for TA-8995. “A key milestone will be reached in August when the readout of the phase 2b TULIP study in 364 patients with mild dyslipidemia is planned”, stated Rob de Ree, CEO of Dezima Pharma.
“The start of this new Lp(a) study is another milestone event for Dezima Pharma” said Rob de Ree. “There are currently no approved or effective drug treatments available for patients with elevated Lp(a) levels. These patients are at continuous risk of cardiovascular events from an early age. TA-8995 has the potential to be a breakthrough drug for these patients”.
John Kastelein, CSO and co-founder of Dezima added: “The potent Lp(a) reductions achieved in the phase 1 study by TA-8995 will hopefully translate into clinically relevant lowering of this very atherogenic lipoprotein in this study”.
36 male and female subjects with isolated, increased Lp(a) levels will be selected from the Copenhagen General Population Study database and will be randomised to one of two different dosages of TA-8995 or placebo and treated for 12 weeks.
The Lp(a) pilot study will be conducted at the Herlev Hospital in Denmark. Prof. Børge Nordestgaard is the principal investigator of the study.