By Dominic Chopping
STOCKHOLM – Swedish pharmaceutical company Vicore Pharma Holding AB said on Friday that a new application for an investigational drug for its C21 Covid-19 treatment has been accepted by the US Food and Drug Administration.
Acceptance allows for the initiation of the US Phase 3 trials, which will include 600 adult patients hospitalized with Covid-19 who require oxygen support but not mechanical ventilation.
“Vicore’s Phase 2 trial at Covid-19 showed that C21 significantly reduced the extended need for supplemental oxygen therapy, indicating faster recovery with C21 compared to placebo,” the company said.
Preparations for the tests are currently continuing in countries in North America, South and Central America, Europe, Africa and Asia, with first-line results expected during the first quarter of 2022, he said.
“The main goal is to assess the effect of C21 on Covid-19’s recovery,” said Vicore Pharma.
Vicore Pharma is a rare disease pharmaceutical company focused on fibrotic lung disease and related indications.
Write Dominic Chopping at firstname.lastname@example.org