Date: 2014-11-13
Type of information: Completion of patient enrollment
phase: 1b
Announcement: completion of patient enrollment
Company: Dezima Pharma (The Netherlands)
Product: DEZ-001 - TA-8995
Action
mechanism: DEZ-001 is a cholesteryl ester transfer protein (CETP) inhibitor that has already demonstrated clinically relevant improvements on low-density lipoprotein (LDL) and high-density lipoprotein (HDL) levels as well as other lipid parameters in healthy volunteers. The Cholesteryl Ester Transfer Protein (CETP) facilitates the transfer of cholesterol from HDL to other lipoproteins including LDL, in exchange for triglycerides.The CETP mediated transfer of cholesterol into LDL particles results into maturation of those LDL particles to more atherogenic LDL particles, which contribute to macrophage foam cell, and eventually plaque formation. Large Mendelian Randomization studies, epidemiological as well as preclinical studies have provided evidence for the notion that lower CETP activity is inversely related to cardiovascular mortality. In addition, reduced activity of CETP by pharmaceutical means or by naturally occurring mutations in the CETP gene results in increased HDL and decreased LDL levels. This provides a rationale for the inhibition of CETP activity as a therapeutic intervention in dyslipidemic conditions characterized by either low HDL or high LDL cholesterol. The compound was in-licensed from Mitsubishi Tanabe Pharma Corporation.
Disease: subjects with isolated, high Lipoprotein(a) or Lp(a)
Therapeutic area: Cardiovascular diseases - Metabolic diseases
Country: Denmark
Trial details:
Latest
news: * On November 13, 2014, Dezima Pharma, the biotechnology company developing innovative drugs in the field of dyslipidemia, announced the complete enrolment of a study with TA-8995 in asymptomatic subjects with isolated, severely elevated Lipoprotein(a) (Lp(a)). 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). 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. 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. 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.
* On July 9, 2014, Dezima Pharma 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.
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.
