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.
In ATTRACT-3, patients will be randomized to receive 100 mg C21 or placebo twice daily on top of standard of care for 14 days and be followed for 60 days. Trial start-up activities are ongoing at more than 40 clinical sites globally. Topline results from ATTRACT-3 are expected during the first half of 2022.
"The current SARS coronavirus could be just a few mutations away from evading existing COVID-19 vaccines and there is still a huge unmet need for a therapy that could restore lung function in patients with moderate to severe disease," said Carl-Johan Dalsgaard, CEO of Vicore. "ATTRACT-3 is a global trial. Our judicious choices of geographical focus allow us to expect a steady patient recruitment, capture a broad spectrum of virus variants and to be able to report the results on schedule during the first half of 2022."
C21 in COVID-19 – improved respiratory outcomes
Results from the phase 2 ATTRACT trial demonstrated the ability of C21 to significantly reduce the need for supplemental oxygen in hospitalized patients with COVID-19 (90% reduction of risk in C21-treated patients compared to those on placebo at day 14; p=0.003), with numerically fewer deaths and cases of patients requiring mechanical ventilation in the C21-treated group.
C21 - a first-in-class AT2R agonist
C21 is a first-in-class, orally available, low molecular weight, angiotensin II type 2 receptor (AT2R) agonist that activates the "protective arm" of the renin-angiotensin system (RAS). The compound has shown robust effects in human idiopathic pulmonary fibrosis (IPF) lung slices and a phase 2 proof-of-concept trial in IPF is currently ongoing. Given the therapeutic potential of AT2R agonism in several additional indications with significant unmet medical needs, Vicore has intensified the efforts to develop proprietary follow-up molecules with differentiated profiles.
For further information, please contact:
Carl-Johan Dalsgaard, CEO
Phone: +46 70 975 98 63
E-mail: carl-johan.dalsgaard@vicorepharma.com
This information was submitted for publication on September 17, 2021 at 08.00 CET.
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