DalCor Pharmaceuticals today announced the initiation of dal-COVID, a Phase 2 proof-of-concept study for dalcetrapib as a potential oral anti-viral treatment for COVID-19.
The main protease (3CLMpro) of the SARS-CoV-2 virus is a key enzyme that plays a pivotal role in mediating viral replication and transcription. Dalcetrapib is a potential anti-viral treatment as it binds to the catalytic site of 3CLMpro of SARS-CoV-2 in vitro, thereby inhibiting its activity and viral replication.
dal-COVID is a double-blind, placebo-controlled trial in patients with confirmed mild to moderate symptomatic COVID-19. The study will evaluate the efficacy and safety of three different doses of dalcetrapib compared to placebo in approximately 200 adult patients over a 10-day treatment period.
“I am delighted that dalcetrapib is being investigated as an oral antiviral treatment for mild to moderate COVID-19,” said Dr. Guy Boivin, Centre Hospitalier Universitaire de Québec, Université Laval, Quebec City, Canada and Chairman of the Executive Committee for dal-COVID. “Effective oral anti-viral treatments for patients with COVID-19 would significantly improve patient symptoms, reduce complications, and the burden on healthcare systems while contributing alongside vaccines to mitigate the impact of the pandemic.”
dal-COVID will be coordinated by the Montreal Health Innovations Coordinating Center (MHICC). Results are anticipated in Q1 2021.
Dalcetrapib is also currently being evaluated in the dal-GenE Phase 3 cardiovascular precision medicine clinical outcomes trial. To date, it has been administered, with good safety and tolerability profile, for more than two years to over 10,000 patients with cardiovascular diseases and risk factors such as obesity, diabetes, and hypertension.
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 U.S. For more information, please visit dalcorpharma.com.
Dalcetrapib is an investigational therapy that would potentially be 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.