Capricor Therapeutics starts dosing patients in Phase 2 trial of CAP-1002

Capricor Therapeutics announced that the first two patients have been dosed in its Phase 2 study evaluating intravenous infusion of CAP-1002 - its lead clinical asset - using its allogeneic cardiosphere-derived cells technology as a treatment option for patients with COVID-19. The study is now enrolling patients who have been diagnosed with SARS-CoV-2 and require supplemental oxygen. The study is being conducted at multiple sites in the United States and will enroll up to 60 patients. Within the framework of SARS-CoV-2 pathogenesis, multiple pathways known to be CAP-1002 sensitive may serve as therapeutic targets. These targets include pro-inflammatory pathways and anti-inflammatory pathways that have been explored with CAP-1002 in preclinical models of myocardial ischemia, myocarditis, heart failure, muscular dystrophy and pulmonary hypertension. Given that CAP-1002 polarizes macrophages to an anti-inflammatory immunomodulatory phenotype, CAP-1002 may subsequently attenuate cytokine storm. The INSPIRE trial is a Phase 2, randomized, double-blind, placebo-controlled study that will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and are in severe or critical condition as indicated by life-support measures. The primary objectives of the study are to determine the safety and effectiveness of intravenously infused CAP-1002 for improving clinical outcomes in severe to critical patients with COVID-19. Eligible subjects will be randomized to either the CAP-1002 or placebo group and undergo baseline safety and efficacy assessments approximately one to three days prior to the administration of investigational product.