DalCor Announces Completion of Patient Enrollment in dal-GenE, the First Phase 3 Precision Medicine Cardiovascular Outcomes Trial in Coronary Heart Disease
- Category: Small Molecules
- Published on Thursday, 17 January 2019 15:16
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LONDON, UK and MONTREAL, Canada I December 17, 2018 I DalCor today announced the completion of patient enrollment in the dal-GenE study, the first Phase 3 precision medicine cardiovascular outcomes trial in coronary heart disease. The dal-GenE study is evaluating the efficacy of the CETP inhibitor dalcetrapib to reduce clinical cardiovascular events in patients with the AA ADCY9 genotype who have had a recent acute coronary syndrome (ACS). The study has enrolled over 6,000 patients and is being conducted in 680 sites in 32 countries.
“The accelerated enrollment of patients in the dal-GenE study reflects the scientific enthusiasm and commitment among the medical community to bring the right medicine to the right patient” said Dr. Jean-Claude Tardif from the Montreal Heart Institute. “ADCY9 genetic testing to identify the appropriate patients for treatment with dalcetrapib has the potential to provide a genetically targeted therapy to improve clinical outcomes. This approach could pave a new path for the development of precision medicine for cardiovascular disease. Approximately twenty percent of patients carry the specific genotype that has the potential to benefit from treatment with dalcetrapib after an ACS.”
Dr. Donald M. Black, chief medical officer of DalCor added, “The completion of the enrollment of the dal-GenE trial marks an important milestone for DalCor. We are progressing the dal-GenE study with the aim to improve cardiovascular outcomes beyond the current standard of care and look forward to sharing the results of of this event-driven trial, expected in 2021.”
About the dal-GenE Phase 3 Study
The double-blind, randomized, placebo-controlled, multicenter Phase 3 clinical trial is evaluating the efficacy of dalcetrapib in 6,000 patients recently hospitalized with acute coronary syndrome (ACS) and who express the AA genotype at variant rs1967309 in the ADCY9 gene, determined by an investigational companion diagnostic test developed by Roche Molecular Systems (RMS). The primary endpoint of the study is the time to first occurrence of any component of the composite of cardiovascular death, myocardial infarction (heart attack) and stroke. Dalcetrapib is tested on top of typical therapy for patients with acute coronary syndromes (ACS), including lipid management with statins and other LDL-lowering drugs. The trial is being conducted in over 680 sites in 32 countries
DalCor is developing precision medicine by genetically targeting patients who will derive clinical benefits. By integrating clinical and genetic insights, DalCor intends to deliver superior clinical cardiovascular outcomes. The company’s first development program, dalcetrapib, is intended to reduce cardiovascular events in a specific genetic subset of patients. DalCor has a worldwide exclusive license for dalcetrapib together with rights to the genetic marker for use with dalcetrapib and is sponsoring the dal-GenE study. For more information, visit www.dalcorpharma.com.
SOURCE: DalCor Pharmaceuticals