DalCor Announces dal-GenE Trial Continues With Final Data Expected in the First Half of 2021
DalCor Pharmaceuticals recently announced that the independent dal-GenE Data and Safety Monitoring Board (DSMB) recommends the dal-GenE pivotal outcomes trial should continue as planned with no modifications. This is an important milestone for DalCor and for cardiovascular patients with the ADCY9 AA genotype.
“We remain highly confident in the promise of dalcetrapib to bring the first pharmacogenomic precision medicine in cardiovascular disease to post-acute coronary syndrome (ACS) patients with the ADCY9 AA genotype,” said Dr. Fouzia Laghrissi Thode, CEO, DalCor. “We expect the final results of the dal-GenE trial during the first half of 2021.”
“The positive result of the futility analysis in January along with the recent DSMB recommendation reinforce our belief in dalcetrapib and the transformational approach of specifically targeting patients with the ADCY9 AA genotype,” added Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, Professor of Medicine at the University of Montreal, and dal-GenE principal investigator.
Dalcetrapib is potentially the first pharmacogenomic precision medicine in cardiovascular disease developed for patients with the ADCY9 AA genotype. It is currently being evaluated in the dal-GenE Phase 3 cardiovascular clinical outcomes trial aiming to deliver a relative risk reduction of 15% or greater for major adverse cardiovascular events (MACE). dal-GenE passed a futility analysis in January 2020 and trial completion is expected in the first half of 2021.
A companion diagnostic test, developed in conjunction with Roche Molecular Systems, identifies patients with the ADCY9 AA genotype who may potentially benefit from dalcetrapib treatment. DalCor obtained global rights to develop, manufacture and commercialize dalcetrapib under a license and collaboration agreement with Roche.
DalCor would like to thank all the patients, investigators, and study sites for their continued participation in the dal-GenE study.
DalCor is a biopharmaceutical company with a focus on addressing cardiovascular disease, the greatest global healthcare burden. Our purpose is to deliver the first pharmacogenomic precision medicine in cardiovascular disease that specifically targets patients with the ADCY9 AA genotype. The company has operations in Canada, the UK, Switzerland, and the US. For more information, please visit dalcorpharma.com.
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