Formycon AG has received the consent from the Paul Ehrlich Institute (PEI) regarding the proposed development concept for COVID-19 therapeutic FYB207. This marks another milestone for the development of the ACE blocker.
The national federal institute for Vaccines and Biomedicines supports Formycon's Formycon’s approach in the further development of the SARS-CoV-2 blocker FYB207. Agreed upon were primarily the analytics, process development, manufacturing, preclinical development, and phase I and II clinical trial concept, including the associated bioanalytical strategy. In addition, the review of clinical trial applications is expected be conducted under an accelerated process.
SARS-CoV-2 and other corona viruses use the surface protein ACE2 on human cells as a entry portal for respiratory infection. Formycon developed FYB207 together with its academic partners Prof. Ulrike Protzer, Chair of Virology, and Prof. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich. For this purpose, the human ACE2 protein was linked to the constant part of human antibodies. The risk of infection enhancement by vaccines and antibodies described for corona viruses is minimized by using the IgG4 portion in the fusion. FYB207 also has a natural enzymatic activity that may provide additional protection for the lungs and cardiovascular system in symptomatic patients. Because ACE2 is the human receptor for the spike protein of SARS-CoV-2, Formycon claims FYB207 can also be used against viral mutants and other coronaviruses.
In addition, the Planegg-based company is preparing a Scientific Advice Meeting with the U.S. Food and Drug Administration (FDA) and has assured GMP manufacturing capacity for FYB207 with an experienced German manufacturer.
“We are delighted about the positive feedback from the Paul-Ehrlich-Institute and feel confirmed in the development approach of FYB207. Especially in terms of virus mutations, an effective drug becomes an indispensable cornerstone in the fight against the corona pandemic. With FYB207, we are developing an important treatment option for COVID-19 patients while also contributing to the prevention of outbreaks of future corona viruses”, says Dr. Carsten Brockmeyer, CEO of Formycon AG.
Dr. Stefan Glombitza, COO of Formycon AG adds: “The consultation with the Paul-Ehrlich-Institute has provided us with clarity for our approach in the development of FYB207. The speed with which we are advancing this program from initial laboratory studies to entry into clinical trials reflects the high level of commitment of all parties involved. People infected with SARS-CoV-2 and at risk of severe illness or even death urgently need effective medicines.”