NEW YORK – DalCor Pharmaceuticals on Wednesday said it raised $80 million in a Series D financing round, which it will use to try to confirm the efficacy of the CETP inhibitor dalcetrapib in treating cardiovascular disease using a biomarker strategy.
Fonds de Developpement Économique from the Québec government, Andes Growth, TB Pharma, Fonds de Solidarité FTQ, and CTI Life Sciences participated in the funding round.
The financing will allow DalCor to continue studying dalcetrapib, which the Montreal-based drugmaker obtained global rights to develop, manufacture, and commercialize through a 2015 licensing agreement with Roche. In the Phase III dal-GenE trial, however, the drug failed to reduce risk of a composite endpoint of cardiovascular death, resuscitated cardiac arrest, nonfatal myocardial infarction, or nonfatal stroke compared to placebo among patients with recently documented acute coronary syndrome and the AA genotype at variant rs1967309 in the ADCY9 gene. There was, though, a 21 percent reduction in the relative risk of fatal and nonfatal myocardial infarction in patients across 34 countries and a 45 percent reduction in relative risk specifically in patients in North America.
"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 [US Food and Drug Administration] to conduct the Dal-GenE-2 confirmatory trial to support a potential new drug application filing," DalCor CEO Fouzia Laghrissi Thode said in a statement.
The Dal-GenE-2 trial is a double-blind, randomized placebo-controlled study that DalCor will conduct in North America under a special protocol assessment agreement with the FDA. Investigators will assess whether dalcetrapib reduces the occurrence of fatal and nonfatal myocardial infarction in patients with recent acute coronary syndrome and the ADCY9 gene mutation.
DalCor expects to begin the Dal-GenE-2 trial in Q3 and to conduct an interim efficacy analysis in 2026. The company said the study will conclude in 2027.