Apeiron Biologics gets regulatory approval for Phase II Covid-19 trial

3rd April 2020 (Last Updated April 3rd, 2020 12:50)

Apeiron Biologics has secured approvals from regulatory agencies in Austria, Germany and Denmark to conduct a Phase II clinical trial of APN01 for the treatment of Covid-19.

Apeiron Biologics gets regulatory approval for Phase II Covid-19 trial
This illustration, created at the CDC, reveals ultrastructural morphology exhibited by the 2019 novel coronavirus. Credit: CDC/ Alissa Eckert, Dan Higgins.

Apeiron Biologics has secured approvals from regulatory agencies in Austria, Germany and Denmark to conduct a Phase II clinical trial of APN01 for the treatment of Covid-19.

APN01 is the recombinant version of the human angiotensin-converting enzyme 2 (rhACE2) with a dual mechanism of action.

The drug candidate is designed to imitate human ACE2 used by the virus to enter host cells. It is believed to possess the potential to inhibit the Covid-19 infection and reduce lung injury.

The inhibition is expected to be possible as the virus attaches to soluble ACE2/APN01, rather than ACE2 on the cell surface, making the virus incapable of further infecting the cells.

In addition, the drug candidate mitigates the harmful inflammatory reactions in the lungs and protects against acute lung injury (ALI)/acute respiratory distress syndrome (ARDS).

Apeiron Biologics CEO Peter Llewellyn-Davies said: “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.”

The randomised, double-blind Phase II trial will assess APN01 compared to placebo in up to 200 patients at ten sites in Austria, Denmark and Germany.

Primary objective is safety and clinical efficacy of APN01 in severe Covid-19 patients who require invasive mechanical ventilation.

The trial’s secondary objectives include measurable biological biomarker changes.

Austrian Government has committed to fund the trial partially.

In previous Phase I and Phase II studies, APN01 demonstrated favourable safety and tolerability profile in a total of 89 healthy participants and patients with pulmonary arterial hypertension (PAH) and ALI/ARDS.