This article is more than 5 years old. Information may no longer be current.
Enrollment for phase 3 trial of dalcetrapib completed
Click Here to Manage Email Alerts
DalCor announced that it has completed patient enrollment for a phase 3 trial that will assess the efficacy of a cholesteryl ester transfer protein, or CETP, inhibitor in addition to standard care for the treatment of patients with a particular genotype who had a recent ACS event.
The dal-GenE trial has enrolled more than 6,000 patients from 680 sites in 32 countries to evaluate the effectiveness of dalcetrapib, according to a press release from DalCor. In this double-blind, randomized, placebo-controlled trial, patients are assigned dalcetrapib with standard therapy or standard therapy alone.
“What the study is doing is bringing benefit on top of the standard of care,” Fouzia Laghrissi-Thode, MD, CEO of DalCor, told Cardiology Today. “If the study brings what we expect, at least 20% benefit on top of that, it will change the way patients are treated in the clinical setting.”
The primary endpoint is time to first occurrence of any component of the composite of MI, CV death and stroke.
Before randomization, patients underwent a diagnostic test, which was developed by Roche Molecular Systems, to determine whether they carry the AA genotype at variant rs1967309 in the ADCY9 gene. The specific gene was selected based on previous results from the dal-OUTCOMES trial, as it identified the gene that predicted a response to the treatment, Laghrissi-Thode said.
“The gene of interest, ADCY9, is present in about 20% of the patient population who have ACS, and this is in Caucasians,” Laghrissi-Thode said during an interview. “If you look at the incidence in other groups like African-Americans or Asians, that incidence goes even higher than 20%.”
In the overall findings of dal-OUTCOMES, raising HDL with dalcetrapib did not improve CHD death, nonfatal MI, ischemic stroke, unstable angina or cardiac arrest with resuscitation in a cohort of 15,871 patients with ACS.
Results of the dal-GenE trial are expected in the next few years.
“Around the end of 2020 or first half of 2021, we will know if this product will bring value to patients,” Laghrissi-Thode told Cardiology Today. – by Darlene Dobkowski
Disclosure: Laghrissi-Thode is an employee of DalCor.