Vicore Pharma Holding AB (publ), a pharmaceutical company dedicated to developing innovative medicines for severe lung disorders, today reports an expanded data analysis to follow up the encouraging top-line data from the ATTRACT study reported on December 8, 2020. The data show restoration of lung function in COVID-19 with the company's oral lead candidate drug C21, suggesting that C21 can become an important complement to vaccines to combat the COVID-19 pandemic. A webcast presentation will be held today at 15:00 CET (9:00 am EST).

With COVID-19 increasing worldwide, with more than 600,000 new cases and 10,000 deaths registered per day, there is an urgent need for a safe oral effective therapy as an important complement to the recently launched vaccine efforts.

"The critical incident in COVID-19 that makes this disease different from 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".

Updated summary of results   

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. 

Study design     

In the ATTRACT study (Angiotensin II Type Two Receptor Agonist COVID-19 Trial), 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 acute respiratory infection but not requiring mechanical ventilation were recruited. The patients were randomized to receive oral treatment with C21 (100 mg b.i.d., n=51) or placebo (n=56) for seven days on top of standard of care (physician's choice) with a follow up after 7-10 days.  According to data analyzed to date, the treatment groups were well balanced regarding age, sex, and concomitant medications.  Importantly, the vast majority of patients received corticosteroid treatment.

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 IPF lung slices, and a phase II 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.