Vicore starts dosing of first COVID-19 patients in the global phase 3 trial ATTRACT-3

GOTHENBURG, Sweden, Sept. 17, 2021 /PRNewswire/ -- Vicore Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical company developing innovative medicines for severe lung disorders today announces the dosing of the first patients in the company's global phase 3 trial of C21 in COVID-19 (ATTRACT-3).            

• Previously reported positive phase 2 trial results strongly support further evaluation of the Vicore AT2 receptor agonist C21 in COVID-19            
• The pivotal phase 3 trial is currently approved in the US, Ukraine, South Africa, Brazil, Czechia, Philippines and India to investigate the efficacy and safety of C21 in hospitalized patients with COVID-19

ATTRACT-3 is the pivotal trial in which C21, an angiotensin II type 2 receptor (AT2R) agonist, is tested for the treatment of COVID-19 with the objective of generating key efficacy and safety data for assessment by regulatory bodies, including the US FDA. The first doses have now been administered and currently 9 sites are initiated in the US, Ukraine, Brazil, and South Africa.

"There remains a need for an efficient treatment of patients with COVID-19. To date, only 31% of the global population has been fully vaccinated and the rapid emergence of virus variants threatens to complicate control of the disease. Based on positive results from the phase 2 trial, we look forward to investigate the efficacy and safety of C21 in COVID-19," said Dr. Maureen Horton, M.D., Professor of Medicine at Johns Hopkins University School of Medicine and the coordinating investigator of ATTRACT-3.

ATTRACT-3 is a randomized, double-blind, placebo-controlled, multinational, phase 3 trial which will include 600 adult patients hospitalized with COVID-19 requiring oxygen support but not mechanical ventilation. The primary objective is to evaluate the effect of C21 on recovery from COVID-19. Vicore's phase 2 trial in COVID-19 (ATTRACT) showed that C21 significantly reduced the extended need for supplemental oxygen therapy, indicating faster recovery for patients treated with C21 compared to placebo.