Dezima Completes Patient Enrolment for TULIP Phase 2b Study
News Jan 13, 2014
Dezima Pharma has announced 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.