MONTREAL, 13 September, 2023 – DalCor Pharmaceuticals today announced the closing of the company’s Series D financing round of $80m USD to conduct the Dal-GenE-2 confirmatory trial in North America under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
Dal-GenE-2 (Dal-302), a phase III, double-blind, randomized placebo-controlled study, will evaluate the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal myocardial infarction (MI) in approximately 2,000 patients with a documented recent acute coronary syndrome (ACS) and the AA genotype at variant rs1967309 in the ADCY9 gene.
“Following the dal-GenE trial results showing a potential benefit in a genetically defined patient population, we are pleased to have reached agreement with the FDA to conduct the Dal-GenE-2 confirmatory trial to support a potential new drug application (NDA) filing,” said Dr. Fouzia Laghrissi Thode, CEO of DalCor Pharmaceuticals.
This confirmatory trial follows the results of the dal-GenE trial which showed a 21% relative risk reduction (RRR) in fatal and non-fatal MI in 6,149 patients across 34 countries, and a 45% RRR in 1,200 patients in North America and confirmed the safety profile of dalcetrapib.
“The AA genotype frequency is up to 20% in European populations and is higher than 40% in populations of African ancestery,” said Dr Eldrin F. Lewis, Chief of the Division of Cardiovascular Medicine at Stanford University, Professor of Cardiovascular Medicine, and Chair of the Dal- GenE-2 diversity committee. “With the relative risk reduction seen in North American patients in the dal-GenE study and the continued commitment to investigating the first potential pharmacogenetic precision medicine for patients with cardiovascular disease, we are pleased to partner with DalCor Pharmaceuticals in this confirmatory trial.”
The Series D financing includes the participation of Fonds de Developpement Économique from the Québec government managed by Investissement Québec and Fonds Propres d’ Investissement Québec as well as current investors including Andes Growth, TB Pharma, Fonds de Solidarité FTQ, and CTI Life Sciences.
“Québec’s life-sciences expertise is recognized worldwide. Our government is keen to support projects with the potential to generate meaningful spinoffs, like DalCor’s work on cardiovascular health,” said Pierre Fitzgibbon, Minister of Economy, Innovation and Energy, Minister Responsible for Regional Economic Development and Minister Responsible for the Montréal Region.
“We are pleased to support DalCor in this round of financing so they can carry on development in precision medicine for cardiovascular disease,” said Guy LeBlanc, President, and CEO of Investissement Québec. “Their research can ultimately revolutionize their industry and reduce the number of cardiovascular events. Investissement Québec will keep supporting emerging young businesses to position Québec in key sectors of our economy, such as life sciences.”
Dal-GenE-2: The primary objective of Dal-GenE-2 is to evaluate the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal myocardial infarction in 2,000 patients with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene. The trial is expected to start in Q3 2023 with an interim efficacy analysis in 2026, and completion anticipated in 2027.
Dal-GenE: While the trial missed the primary endpoint, most likely due to the impact of the COVID-19 pandemic, the results show a 21% relative risk reduction (RRR) in fatal and non-fatal MI in 6,149 patients across 34 countries, and 45% RRR in 1,200 patients in North America. These data support the further development of dalcetrapib.
DalCor Pharmaceuticals: DalCor Pharmaceuticals is pioneering precision medicine for patients with cardiovascular disease. By combining genetic and clinical insights, the company’s development program, dalcetrapib, is intended to reduce fatal and non-fatal myocardial infarction (MI) following a recent acute coronary syndrome and deliver superior cardiovascular outcome in a specific genetic subset of patients.
DalCor Pharmaceuticals holds the worldwide exclusive license to develop, manufacture and commercialise dalcetrapib, and holds the right to the genetic marker for use with dalcetrapib in patients with the AA genotype at variant rs1967309 in the ADCY9 gene. A companion diagnostic test, developed in conjunction with Roche Diagnostics, identifies patients with the ADCY9 AA genotype who may potentially benefit from dalcetrapib treatment.
For more information, visit www.dalcorpharma.com.