A possible Covid-19 drug from the Viennese company Apeiron has shown a significant reduction in the number of days with mechanical ventilation and the viral load in seriously ill patients in the phase 2 study. The treatment has proven to be safe and well tolerated. “This encourages us to continue the development of this promising therapeutic development candidate,” reported the university professor and Apeiron founder Josef Penninger on Friday.
The study with hospitalized patients was carried out in Austria, Germany, Denmark and Russia, the biotechnology company announced in a broadcast. Of 178 seriously ill Covid-19 patients, 88 received the agent called APN01 (Alunacedase alpha) and 90 received a placebo and a standard treatment. The patients were treated for seven days and examined in the study for a total of 28 days.
Reduction of the viral load
The results showed statistical significance for the improvement in the number of days without mechanical ventilation and the reduction in the viral RNA load. Treatment with APN01 also had a positive effect on central biomarkers of the renin-angiotensin system (RAS). This is a confirmation of the effect of the treatment. A shortened time under mechanical ventilation could also significantly reduce the risk of medical complications and comorbidities (accompanying diseases) and at the same time relieve intensive care units and the entire health system. In addition, the APN01 treatment was examined according to the eleven-point scale of the World Health Organization (WHO), the clinical condition of the patient is assessed according to defined parameters. According to Apeiron, these results show an improvement in important clinical parameters.
APN01 is the recombinant form of the human angiotensin-converting enzyme 2 (rhACE2) and mimics the natural form of ACE2, a receptor that is considered to be the essential gateway for the SARS-CoV-2 virus into the cell and a crucial role in the Treatment of Covid-19 plays. The virus uses its spike proteins to bind to ACE2 on human cells in order to penetrate them. APN01, the soluble form of ACE2, can prevent the binding of the virus spike protein to the cell surface receptor and thus the infection of cells, the broadcast said.
The virus is “locked out”
“This important study supports the results of our research and previous APN01 development programs in other SARS viruses and related severe respiratory diseases. As shown in this study, APN01, the recombinant form of human ACE2 protein, may ‘lock the door’ to the virus it uses it to get into the cells. In addition, the tissue can be protected by the regulation of the Ang II factor in the RAS system, “explained Josef Penninger, co-inventor of APN01 and professor at the University of British Columbia in Canada.
“The recently emerged virus variants, which could be resistant to antibody drugs or even to vaccines, still require ACE2 as a receptor and entry point into the cell. APN01 could thus become an essential part of a global therapy repertoire against these variants as well as against variants which occur in the future, “reported Penninger. “We will now discuss the next steps in the further development of APN01 with the study doctors, consultants and the regulatory authorities in order to be able to realize a treatment option for this deadly disease,” announced Apeiron CEO Peter Llewellyn-Davies.