Dezima Initiates Phase 2b TULIP Study on CETP Inhibitor Program DEZ-001
News Aug 30, 2013
Dezima Pharma has announced the initiation of a double blind, placebo controlled, Phase 2b dose ranging study of DEZ-001 (previously TA-8995), alone and in combination with statins, in order to study the effects on a wide range of lipids and other biomarkers of cardiovascular disease (CVD) in patients with mild dyslipidaemia.
The TULIP (“TA-8995: its Use in patients with mild dysLIPidemia”) study will take place in specialized centres across Denmark and the Netherlands and will investigate the effects of different doses of DEZ-001 on established CVD biomarkers over a 3 month dosing period.
DEZ-001 is a 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.
Professor John Kastelein, Chief Scientific Officer and founder of Dezima, commented, “I am very pleased that the TULIP study has kicked off with this very promising new compound for patients with dyslipidemia. If successful, this trial will pave the way for larger scale Phase 3 pivotal clinical trials.”
“The start of the TULIP study is an exciting milestone for Dezima Pharma,” Rob de Ree, CEO of Dezima added.
Ree continued, “Being the most potent CETP inhibitor in clinical development with excellent safety, pharmacokinetic and pharmacodynamic properties we firmly believe that our compound can further improve the outcome for patients suffering from cardiovascular disease due to dyslipidaemia.”
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 €14.2m from a Series A financing with participation of Forbion Capital Partners, BioGeneration Ventures and New Science Ventures, and a loan from the Agentschap NL, an agency of the Dutch Ministry of Economic Affairs.
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.
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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