Vicore Pharma Holding AB (publ), a rare disease pharmaceutical company developing innovative medicines for severe lung disorders, announced on Friday that it dosed its first patient in its global phase three trial of C21 to treat COVID-19.
The trial, ATTRACT-3, tests C21, an angiotensin II type 2 receptor agonist, to treat COVID-19 with the aim of generating key efficacy and safety data for evaluation by regulatory bodies, including the US FDA. The first doses are now administered and presently nine sites are initiated in the US, Ukraine, Brazil, and South Africa.
The trial is being conducted on 600 adult patients hospitalised with COVID-19 needing oxygen support but not mechanical ventilation. Its main aim is to assess the effect of C21 on recovery from COVID-19. Patients will be randomised to receive 100 mg C21 or placebo twice daily on top of standard of care for 14 days and be followed for 60 days. Top-line results from the trial are likely to be revealed in the first half of 2022.
The company says that results from the phase 2 ATTRACT trial demonstrated C21's ability to significantly reduce the need for supplemental oxygen in hospitalised 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.
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