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Dezima Pharma Completes Patient Enrolment for TULIP Phase 2B Study With CETP Inhibitor TA-8995


1/13/2014 12:24:11 PM

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Naarden, The Netherlands, 13 January 2014 – Dezima Pharma (‘Dezima’), the biotechnology company developing innovative drugs in the field of dyslipidemia, announced today the completed enrolment of its phase 2b TULIP study. The aim of the study is to investigate the effects of TA-8995 (DEZ-001), a potential best-in-class CETP inhibitor, in around 360 patients with mild dyslipidemia on a wide range of plasma lipids, lipoproteins and validated biomarkers of cardiovascular disease (CVD).

Recruitment for the double-blind, placebo-controlled, phase 2b dose ranging study of TA-8995 started in August 2013. The study has seen rapid enrolment in 17 specialized centres across the Netherlands and Denmark. The study has nine arms with patients receiving TA-8995 alone and in combination with statins.

John Kastelein, CSO of Dezima commented: “Completion of the TULIP study will define the safe and effective dose to move TA-8995 rapidly into phase 3 development.”

“We are very pleased with the fast pace of enrolment at the participating centres, showing the outstanding commitment of the investigators” added Rob de Ree, CEO of Dezima Pharma. “The projected read-out of the study will occur in the second quarter of 2014.”

In addition, Dezima Pharma is currently preparing and executing a range of pre-clinical and clinical phase 3 enabling studies around its lead product, including a DDI study and a TQT study under an IND, in order to have a comprehensive partnering package.

In phase 1 studies, TA-8995 has also shown a potent effect on Lp(a), an independent, major risk factor for cardiovascular disease. Rob de Ree commented: “Severely elevated Lp(a) is an unmet clinical problem because these patients are at a high risk of cardiovascular disease such as myocardial infarction, stroke and aortic valve stenosis. We believe TA-8995 has break-through potential in the treatment of patients with isolated, elevated Lp(a) levels, because it robustly lowered Lp(a) in our phase 1 program.” John Kastelein added: “We will initiate a pilot clinical study in subjects with isolated severely elevated levels of Lp(a) to demonstrate efficacy and safety of TA-8995 in these high-risk patients.”

Dezima Pharma was founded in 2012 by John J.P. Kastelein, Professor of Medicine at the Department of Vascular Medicine at the Academic Medical Centre, University of Amsterdam. The Company recently raised €14.8 m from a Series A financing with participation of Forbion Capital Partners, BioGeneration Ventures and New Science Ventures, and a loan from the AgentschapNL, an agency of the Dutch Ministry of Economic Affairs which was recently extended. Dezima Pharma focuses on the development of novel products to treat dyslipidemic patients suffering from cardiovascular disease. Its lead program DEZ-001 involves the development of the CETP inhibitor TA-8995, which was in-licensed from Mitsubishi Tanabe Pharma Corporation.

About Dezima Pharma B.V.

Dezima Pharma was founded in 2012 by Prof. John Kastelein, Professor of Medicine at the Department of Vascular Medicine at the Academic Medical Center of the University of Amsterdam, The Netherlands, and financed by Forbion Capital Partners, BioGeneration Ventures and New Science Ventures, to develop novel products to treat dyslipidemic patients suffering from cardiovascular disease (CVD). The company’s lead product DEZ-001 (previously TA-8995) has been in-licenced from Mitsubishi Tanabe Pharma Corporation and is a potentially best-in-class CETP inhibitor. The company has an outstanding Scientific Advisory Board including world-leading experts in the dyslipidemia space such as Dr Philip Barter, Professor at The Heart Research Institute, Sydney, Australia, and Dr Bryan Brewer, Senior Research Consultant of Lipoprotein and Atherosclerosis Research at the Medstar Research Institute, Washington DC, USA. About dyslipidemia and CETP inhibitors

Dyslipidemia is a generally asymptomatic disease in which serum lipid levels deviate from the normal level. It is considered to be a modifiable risk factor for cardiovascular disease due the direct relation with atherosclerosis. The market for dyslipidemic drugs, including statins, fish oils and fibrates, topped $25Bn in 2010. Though current treatment is relatively effective a high unmet need remains: about 60% of treated patients have a considerable chance of experiencing a cardiovascular event, which comes with significant morbidity and mortality.

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 CETP activity is inversely related to cardiovascular mortality and 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 inhibition of CETP activity as a therapeutic intervention in dyslipidemic conditions characterized by either low HDL or high LDL cholesterol.

Issued for and on behalf of Dezima Pharma by College Hill.
For more information please contact:
Dezima Pharma:
Rob de Ree
rderee@dezimapharma.com
+31 35 699 3000
For media enquiries on behalf of Dezima Pharma:
College Hill Life Sciences
Melanie Toyne-Sewell / Cora Kaiser
+44 20 7457 2029 / +49 89 5700 1806
dezima@collegehill.com

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