Dezima Pharma Announces Complete Enrolment Of CETP Inhibitor TA-8995 Study In Subjects With Isolated, Elevated Lipoprotein(a) Levels

Readout of the study is planned for the first quarter 2015

Naarden, The Netherlands, 13 November 2014 – Dezima Pharma (‘Dezima’), the biotechnology company developing innovative drugs in the field of dyslipidemia, today announced the complete enrolment of a study with TA-8995 in asymptomatic subjects with isolated, severely elevated Lipoprotein(a) (Lp(a)), which was initiated in September of this year.

The aim of this study, that enrolled 42 male and female subjects from the Copenhagen General Population Study database, is to investigate the Lp(a) lowering effects of TA-8995 (DEZ-001), a best-in-class CETP inhibitor. The subjects have been randomised to one of two different doses of TA-8995 or placebo and will be treated for 12 weeks. The Lp(a) pilot study is being conducted at the Herlev Hospital, Copenhagen University Hospital in Denmark.

Prof. Børge Nordestgaard, principal investigator of the study, commented: “This will be a very important study because at present, we cannot offer these patients any specific therapy and I am looking forward to finding out the effects of TA-8995 on Lp(a) levels in this population”.

Lp(a) is an independent major risk factor for cardiovascular disease and aortic valve stenosis. In previous phase 1 studies in healthy volunteers with normal baseline Lp(a) levels, as well as in the phase 2b TULIP study, TA-8995 has shown a potent effect on Lp(a) plasma levels.

“After the positive results in the Phase 2b TULIP trial with TA-8995 in general dyslipidemia we also want to explore its potential for this different patient population” said Rob de Ree, CEO at Dezima.

John Kastelein, CSO and co-founder of Dezima added: “Now that Lp(a) levels are proven to be causal in the pathway to cardiovascular disease, we desperately need a pharmacological therapy to lower them. TA-8995 might be such therapy. Therefore, we are very happy that Prof. Nordestgaard has so expeditiously enrolled all patients in this exciting study.“

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