LONDON and MONTREAL, March 7, 2017 – DalCor Pharmaceuticals today announced it is ahead of the enrollment schedule with the randomization of over 1,000 patients of the expected 5,000 patients planned for the Phase 3 “dal-GenE” clinical trial, a cardiovascular outcomes study of dalcetrapib in patients with acute coronary syndrome (ACS) and the AA genotype in the ADCY9 gene. Patients have been recruited at 642 hospitals in 30 countries, including the U.S., and on six continents.
The worldwide clinical trial is led by the Montreal Health Innovations Coordinating Center (MHICC), the Lead Academic Research Organization (ARO) and Medpace a leading Clinical Research Organization (CRO).
Approximately 1 in 5 of the general population harbor the AA genotype.
Jean-Claude Tardif, C.M., M.D., director of the Research Center at the Montreal Heart Institute and professor of medicine at the Université de Montréal, and Principal Investigator for dal-GenE said, “We are pleased and gratified that recruitment goals are ahead of schedule. This is a testament to the need for precision medicine in this critically important sector of medicine; the DalCor approach is the first for cardiovascular medicine. Furthermore, it clearly shows the interest in the study and the necessity for a new therapeutic alternative for patients.”
Marc Pfeffer, Dzau Professor of Medicine, Harvard Medical School, Senior Physician, Brigham and Women’s Hospital, Consultant to the dal-GenE executive committee and chair of the prior dal-Outcomes Safety Committee, said, “This impressive recruitment despite requiring a specific genotype reflects well on both DalCor’s experienced international leadership team as well as the motivation of sites and their patients to be part of this major trial addressing a genetically targeted “precision medicine” approach. When completed, dal-GenE will be the first major test of pharmacogenetically profiling patients to improve prognosis following a recent myocardial infarction.”
Donald Black, M.D., chief medical officer of DalCor, said, “This significant milestone is the result of the efforts of multiple parties collaborating around the world. Our clinical team, in partnership with a strong network of investigators and other groups, such as ANMCO in Italy, GLCC in New Zealand and ECLA in Argentina and Chile, have been able to work together and significantly improve the study’s recruitment rate. It is the hard work of the dedicated team that has enabled the surprisingly quick physician response that has enabled DalCor to reach this important milestone in the short time since initiation.
We believe this compound has a unique profile and possesses a unique combination of safety and efficacy attributes for targeted patients which has the potential to greatly improve outcomes for patients worldwide.
There is much ahead, but DalCor is committed to completing this high-quality trial to obtain a reliable answer to this important question. For now, we look forward to continuing our clinical work in the dal-GenE trial, where we expect to demonstrate a significant reduction in heart attacks, strokes and cardiovascular deaths with the addition of dalcetrapib to the standard of care including statins in patients with ACS and the appropriate genetic profile.”
Dalcetrapib is the first precision medicine in the cardiovascular space to have reached full-scale development with this Phase III clinical study. Over 17,000 patients have participated in dalcetrapib clinical trials to date.
In 2012, investigators at the Montreal Heart Institute led by Professors Jean-Claude Tardif and Marie-Pierre Dubé found a significant association between the effects of dalcetrapib in altering CV events and the polymorphism at the rs1967309 location in the adenylate cyclase type 9 (ADCY9) gene. Patients with the AA genotype had a 39% reduction in CV events when treated with dalcetrapib compared to placebo, while GG patients had a 27% increase and AG patients had a neutral effect. This analysis was conducted in 5749 patients. A prospective analysis of the dal-Plaque 2 study data has also demonstrated reduced atherosclerosis in the AA population when treated with dalcetrapib, but an increase in atherosclerosis in the GG population.
About the dal-GenE Study
The double-blind, randomized, placebo-controlled, multicenter Phase 3 clinical trial will enroll 5,000 patients recently hospitalized with 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. The trial will be conducted at 880 sites in 33 countries.
About DalCor Pharmaceuticals
DalCor is developing precision treatments by genetically targeting patients that 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 secured a worldwide exclusive license for dalcetrapib together with rights to the genetic marker for use with dalcetrapib and is sponsoring the dal-GenE study, which is planned to include 5,000 patients to prospectively confirm the results of the pharmacogenomic analysis in the dal-Outcomes study in a patient population with the AA genotype at the rs1967309 location in the ADCY9 gene.
DalCor Pharmaceuticals has offices in Montreal, San Mateo, Calif., Zug, Switzerland and Stockport, U.K. For more information, visit www.dalcorpharma.com
About the Montreal Heart Institute
Founded in 1954 by Dr. Paul David, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training and prevention. It is part of the broad network of health excellence made up of Université de Montréal and its affiliated institutions. The Montreal Heart Institute ranks as the No. 1 research hospital in Canada for research intensity and research funds per researcher, according to Research Infosource. For more information, please visit www.icm-mhi.org
Donald M. Black, MD