Apeiron Biologics AG has received regulatory approvals in Austria, Germany and Denmark to kickoff a Phase II clinical 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 (COVID-19), and reduce lung injury. The Phase II trial aims to treat 200 severely infected COVID-19 patients, and the first patients are expected to be dosed shortly.
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).
Peter Llewellyn-Davies, Chief Executive Officer of APEIRON Biologics AG, said that, based on its unique dual mechanism of action, APN01 has the potential to be the first drug approved to treat COVID-19 that specifically targets the new SARS-CoV-2 virus. “We look forward to dosing the first patient in our Phase II trial shortly, with the goal of providing a safe and effective treatment option for severely infected COVID-19 patients in urgent need of help. We are grateful to the regulatory authorities in Austria, Germany and Denmark for rapidly approving this study, and for the commitment of the Austrian Government, which has agreed to fund a significant portion of this trial.”
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.
Importantly, the novel coronavirus strain SARS-CoV-2 is a very close relative of the first SARS-CoV virus, which emerged globally in 2002, as it critically relies on the ACE2 receptor to infect the human cell, explained Prof. Josef Penninger, co-inventor of APN01, founder of APEIRON Biologics AG, member of its supervisory board and Professor at the University of British Columbia. “There is significant scientific evidence suggesting that treatment with the dual action recombinant human ACE2 can be used to treat patients with COVID-19. We are blocking the door for the virus and, at the same time, protecting tissues, which is what ACE2 normally does.”
“We are eager to participate in this very promising and critical study. APN01 is an advanced drug candidate with a very strong dual rationale that may provide an important therapeutic contribution to fight the COVID-19 pandemic,” said Prof. Henning Bundgaard, principal investigator of the study and professor at the Faculty of Health and Medical Sciences at the University of Copenhagen.