Resverlogix Corp. announced that the U.S. Food and Drug Administration has granted the Company's request for a Type C meeting to review the clinical trial protocol for its Phase 3 study of apabetalone in high-risk COVID-19 outpatients. The meeting is scheduled for early August.

In response to the transformation of the COVID-19 pandemic, advancement to the Phase 3 trial will target outpatients with multiple risk factors for serious outcomes, focusing where apabetalone has the potential to impact patient outcomes. Company will conclude its Phase 2 trial in hospitalized COVID-19 patients early, thus focusing its resources on the advanced Phase 3 program. By targeting outpatients with multiple risk factors for serious outcomes, Company aims to lessen the strain on healthcare systems ­ keeping COVID-19 patients out of hospitals by reducing disease severity in the short and long-term.

CORAL Study Design. The Phase 3, multicenter, randomized clinical trial, entitled: A Double-Blind Placebo Controlled Study to Assess the Efficacy and Safety of Oral Company in Elderly Subjects with Covid-19 Infection and High Risk for Severe Illness and to Explore the Potential to Limit Long-Term Symptoms, will evaluate the safety and efficacy of Company in preventing serious health outcomes in high-risk COVID-19 patients. Study site selection is currently underway, with sites expected in the United States, Canada, and the Middle East.

High-risk COVID-19 Patients. A recently published, large-scale analysis of electronic health records, found that individuals who have contracted COVID-19 are at significantly greater long-term risk for a broad range of negative cardiovascular outcomes, including acute coronary disease, heart attack, stroke, and heart failure, compared to those who had never had the disease . The study found elevated risks persisted long after the initial infection, even in people who were not hospitalized for COVID-19, and were most pronounced among high-risk patients ­ including those with a history of cardiovascular disease, those with pre-existing comorbidities and those over the age of 65.