APEIRON Biologics AG received regulatory approvals in Austria, Germany and Denmark to initiate a Phase II trial of APN01 to treat COVID-19. APN01 is the recombinant form of the human angiotensin-converting enzyme 2 (rhACE2), and has the potential to block the infection of cells by the novel SARS-CoV-2 virus, and reduce lung injury. The Phase II trial aims to treat 200 severely infected COVID-19 patients.

APN01 has a unique dual mode of action. APN01 imitates the human enzyme ACE2, which is used by the virus to enter cells. The virus binds to soluble ACE2/APN01, instead of ACE2 on the cell surface, which means that the virus can no longer infect the cells. At the same time, APN01 reduces the harmful inflammatory reactions in the lungs and protects against acute lung injury (ALI/acute respiratory distress syndrome (ARDS).

The randomized, double-blind Phase II trial will compare APN01 to placebo in up to 200 patients at 10 sites in Austria, Denmark and Germany. The primary objective of the trial is to assess the clinical efficacy and safety of APN01 in severe COVID-19 patients using, among other criteria, the need for invasive mechanical ventilation. Secondary objectives include the evaluation of measurable biological biomarker changes following treatment with APN01.

APN01 has been shown to be safe and well-tolerated in a total of 89 healthy volunteers and patients with pulmonary arterial hypertension (PAH) and ALI/ARDS in previously completed Phase I and Phase II clinical trials. The product candidate is currently in Phase II development by APEIRON Biologics for the treatment of PAH and ALI/ARDS, which is a significant cause of COVID-19-related mortalities.

CTC North GmbH & Co. KG, a medical contract research organization at the University Medical Center Hamburg-Eppendorf, will be responsible for the study-specific organization of the clinical trial.