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Formycon and Scientists from TUM publish new Data on broadly effective SARS-CoV-2 antiviral Drug FYB207 - Seite 2

SARS-CoV-2 and other coronaviruses use the ACE2 protein on the surface of human cells as a portal of entry for respiratory infections. Formycon has therefore fused the human ACE2 protein to the constant part (Fc) of human immunoglobulin G (IgG4) using computational structural design, creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro. The fusion with the Fc moiety stabilizes ACE2 and prolongs its in vivo efficacy. ACE2 also has inherent enzymatic activity that may provide patients with additional pulmonary and cardiovascular protection. In addition, FYB207 can potentially be used with all other coronaviruses that utilize ACE2 as a portal of entry.

As part of the ongoing in vivo preclinical studies, pharmacokinetics data are being collected in two different models and efficacy data on different variants of the ACE2-Fc fusion proteins are being collected in another model to select the most appropriate candidate for clinical testing. The clinical trial is scheduled to begin in the first half of 2022.

"New variants of concern, such as the omicron variant, demonstrate once again that vaccines and antibodies alone are not sufficient in the SARS-CoV-2 pandemic. Because ACE2 is the entry point for cell infection, SARS-CoV-2 cannot escape the ACE2-Fc fusion proteins. Our ACE2-Fc fusion proteins show consistently strong neutralization in cell cultures of all SARS-CoV-2 viral variants tested to date. Testing of omicron is underway, and we expect high efficacy here as well. Thus, with FYB207, we are developing a highly potent, long-lasting COVID-19 drug directed against all variants. Our ongoing preclinical program is designed to select the best FYB207 drug candidate and thus increase the probability of success for clinical testing," states Dr. Carsten Brockmeyer, CEO of Formycon AG.

"ACE2-IgG4-Fc is a promising antiviral drug candidate for COVID-19 that retains its full antiviral potential against the rapidly spreading SARS-CoV-2 variants. Against the background of further emerging variants of concern, there is a great need for a broadly acting SARS-CoV-2 antiviral agent", says Prof. Dr. Ulrike Protzer, Director of the Institute of Virology at the Technical University of Munich and Helmholtz Center Munich and senior author of the study.