MONTREAL, Sept. 13, 2023 (GLOBE NEWSWIRE) -- 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.