Some 200 seriously ill corona patients in Austria, Germany and Denmark are being given a new drug. Its active substance is APN01. Previous tests with volunteers have shown that the drug is safe and that people tolerate it well. The practical test is being conducted by the Viennese biotechnology company Apeiron.
The founder of Apeiron, Josef Penninger, started researching APN01 about 15 years ago. The active substance was originally intended for the treatment of acute pulmonary diseases. As was recently proven, the main cause of death in Covid-19 is acute respiratory distress syndrome (ARDS).
Twofold effect of APN01
The active ingredient is a synthetic enzyme which potentially has a twofold effect: it could block corona virus infection (SARS-CoV-2) in cells and reduce inflammatory reactions in lungs. APN01 (rhACE2) contains an ACE2 receptor, which is essential for the infection route that was catalyzed by the first SARS epidemic back in 2003. The new SARS-CoV-2 corona virus strain also needs the ACE2 receptor to infect human cells, says Penninger. He teaches at the University of British Columbia. The recombinant ACE2 active ingredient blocks the virus and protects organs.
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Medicine fools the virus
Penninger explained on the Austrian ORF television channel that the active ingredient basically fools the virus. It imitates the enzyme that the virus uses to penetrate cells. As a result, the virus binds to the active ingredient APN01 instead of to a cell surface. This prevents the virus from infecting any cells. The virus is subsequently excreted along with the drug.
The ACE2 receptor
The gene expression of the ACE2 receptor is found in both the mucus membrane of the respiratory tract and in lung tissue. This is the access route that the SARS-CoV-2 virus travels to infect cells. At the same time, ACE2 is also a critical receptor when it comes to SARS-CoV-2 penetration of human cells. Treatment with recombinant human ACE2 can therefore not only be used to inhibit viruses in the blood, but also to protect the lungs and other organs from damage. APN01 is administered intravenously via an IV drip.
Assessing the efficacy
The primary goal of the study is to evaluate the clinical efficacy of APN01 and to assess the safety and tolerability of the compound in patients who are critically ill due to the corona virus. Furthermore, any changes in measurable biological parameters after administration with APN01 will also be evaluated.
Penninger expects that the results of the central clinical trial will be evaluated by summer. If the projections are correct, the company will proceed with acquiring worldwide approval of the APN01 active substance. Then there will no longer be any hurdles to expanding the use of APN01. The researcher told the Austrian media that the substance is already in production.
The test centers:
The research is led by Henning Bundgaard, associated with the Faculty of Health and Medical Sciences at the University of Copenhagen. Other research centers are : University Medical Center Hamburg-Eppendorf and the Klinikum rechts der Isar der Technical University Munich in Germany; the Medical University of Vienna, and the Kaiser-Franz-Josef-Spital in Vienna, Austria; the Medizinische Universität Innsbruck and the University Hospital Salzburg in Austria; and the Danish hospitals including the national Rigshospitalet university hospital in Copenhagen, Herlev and Gentofte Hospital, Hvidovre Hospital and Nordsjællands Hospital Hillerød.
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