Oral Drug That Can Restore Lung Function in COVID-19 Could Complement Coronavirus Vaccine

The expanded data show restoration of lung function in COVID-19 with the company's oral lead candidate drug C21, which 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 IPF lung slices, and a Phase 2 proof-of-concept study in IPF has recently started. Given that AT2R agonism has therapeutic potential in a number of additional indications with significant unmet needs, Vicore Pharma has intensified the efforts to develop proprietary follow-up molecules with different profiles.

In the ATTRACT study, a randomized, double-blind and placebo-controlled trial, a total of 106 hospitalized patients with a diagnosis of coronavirus SARS-CoV-2 infection (confirmed by polymerase chain reaction test) and signs of an acute respiratory infection but not requiring mechanical ventilation were recruited. The patients were randomized to receive oral treatment with C21 (100 mg) or placebo for seven days on top of standard of care (physician's choice) with a follow up after 7-10 days.

The study found that C21 gradually lowered the risk for patients needing oxygen supplementation with reductions of 40% at the end of the 7-day treatment and 57% (p=0.014) at day 8 after start of treatment. At the end of the trial, about a week after the last dose of C21, the effect was even more pronounced, with only one patient in the C21 group still needing oxygen supplementation compared to 11 patients in the placebo group - a reduction by >90%. In the subgroup of patients needing oxygen supplementation (about 30 patients per treatment group), C21 produced a greater reduction of CRP (C-reactive protein) than in the placebo group, an effect that was statistically significant at the predefined 10% level. As reported on December 8, there was a clear trend for C21 reducing the number of patients needing mechanical ventilation and a trend for C21 reducing mortality. The data also showed that the treatment was safe and well tolerated.

The reduced need for oxygen supplementation indicates that C21 stops virus-induced pathological processes in the distal airways and thereby restores lung function. The improvement developed gradually and became more pronounced after the treatment period, and the results suggest that C21 may also be capable of preventing respiratory damage caused by the virus, and in doing so the development of COVID-19.

"The critical incident in COVID-19 that makes this disease different to a common cold is the progression to the distal airways with respiratory distress and subsequent need for oxygen supplementation," said Carl-Johan Dalsgaard, CEO of Vicore Pharma. "Our data clearly show that C21 can restore lung function on top of steroids and normalize gas exchange. A safe oral medication with such properties can become an important complement to vaccines to combat the pandemic."

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