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First Data on Using a Therapeutic Form of ACE2 To Treat COVID-19 Published

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A case report published today in The Lancet Respiratory Medicine outlines the first compassionate use of recombinant soluble human ACE2 (APN01) to treat a female 45-year-old patient who was diagnosed with severe COVID-19.

The published data document multiple indicators of significant improvement her clinical condition after treatment, including a decrease in SARS-CoV-2 viral load, a reduction in inflammatory mediators, and the development of high levels of neutralizing antibodies against SARS-CoV-2.

The findings are the first data on the effect of blocking the Spike protein in a patient with a therapeutic form of ACE2, confirming the mode of action of APN01, and its ability to specifically target SARS-CoV-2. These results continue to support the promise of this novel drug as a treatment to overcome life-threatening illness as well as to stop early infection with the novel coronavirus.

ACE2 is at the center of COVID-19 research and drug development. In this instance, we have now provided first data on soluble ACE2 therapy in a patient with SARS-CoV-2 infection,” comments Dr. Alexander Zoufaly, MD, senior physician in the Department of Infectious Diseases/Clinic in Favoriten, Kaiser Franz Josef Hospital, and first author of the publication. “The results from this named patient use are encouraging, and support the rationale to further explore APN01 as a therapy to treat COVID-19 in Phase II clinical trials.”

ACE2 — a protein on the surface of the cell membrane — was identified by Penninger and colleagues University of Toronto and the Institute of Molecular Biology in Vienna (IMBA) who reported a critical role in protecting organs such as the heart, kidneys, blood vessels, and guarding against lung failure due to infection or aspiration. In earlier work in animal models, the group found that ACE2 is the essential receptor for SARS, the viral respiratory illness recognized as a global threat in 2003. ACE2 also rapidly emerged as the key receptor for the Spike glycoprotein of SARS-CoV-2 in early 2020, placing it at the centre of the response to the COVID-19 pandemic.

“Providing first data on the effect of blocking the viral Spike glycoprotein in patients with COVID-19 is of paramount importance. These data confirm the mode of action of APN01 specifically targeting the SARS-CoV-2 virus,” says
Dr. Josef Penninger, MD, co-inventor of APN01, founder of the developer and manufacturer of the drug, APEIRON Biologics AG, and senior author of the publication. “Our findings from the first SARS epidemic and recent research have identified ACE2 as the critical entry door for both corona viruses, SARS-CoV and SARS-CoV-2, to infect human cells. The new data further support the ability of APN01 to lock the door against the virus.

“Importantly,” adds Dr. Penninger, “in contrast to basically all other drug candidates, APN01 has a dual action – it blocks the virus and can protect the lung, blood vessels and the heart from injury via its enzyme function. These are the tissues that are also affected in severe COVID-19 patients – sometimes with long-term effects – and often the cause of death. The compassionate use findings provide essential data that this important enzyme function of APN01 is preserved in treated COVID-19 patients, and also provide the first data showing that this dual function in one drug might be one of the most rational and promising therapeutic approaches we have. This is now being tested in carefully-designed clinical trials.”

Reference: Zoufaly A, Poglitsch M, Aberle JH, et al. Human recombinant soluble ACE2 in severe COVID-19. The Lancet Respiratory Medicine. doi:10.1016/S2213-2600(20)30418-5