After encouraging results obtained under named patient use in severe cases of COVID-19, F4 Pharma is now preparing clinical trials in several European centers with its substance FX06.

There is emerging evidence that severe COVID-19 affects all organs through a systemic inflammation of the inner layer of the small blood vessels leading to increased permeability of the capillaries, which can finally result in multi-organ failure and death. The dysfunctional endothelium is the link between the pathological pathways of inflammation and coagulation observed in patients with severe COVID-19 and explains the clinical manifestations like thrombosis and disturbed microcirculation. FX06 is able to interrupt this vicious circle by interfering with the inflammatory process, thereby reducing the capillary leak and improving patient outcome.

But severe COVID-19 is not the only disease associated with capillary leak and inflammation. The same pathomechanism can be observed in multiple life-threatening diseases and is regarded as a major complication in intensive care. Therefore, a positive outcome in severely affected COVID-19 patients will serve as the starting point for the clinical development of FX06 in other diseases with a high unmet medical need.

In order to help F4 Pharma’s to advance FX06 and to provide strategic guidance, F4 Pharma has appointed a scientific advisory board consisting of world leading clinicians and scientists.

The scientific advisory board is led by Prof. Kai Zacharowski.

Prof. Dr. Kai Zacharowski is Director of the Department of Anaesthesiology, Intensive Care Medicine & Pain Therapy at the University Hospital Frankfurt, and is currently president of the European Society of Anaesthesiology. His main research focus is on the complex interaction between immune system and coagulation, sepsis and Patient Blood Management. He has developed an evidence-based blood management system which allows a more stringent use of blood transfusions which has an inherent risk of patients to develop severe complications (e.g. myocardial infarction, kidney failure, lung failure, pneumonia).

Dr. Nicolas Bréchot, MD, PhD is Doctor of Intensive Care Medicine at the University of Paris, Pierre et Marie Curie, and is a senior intensivist in the ICU department at the Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris. His main research focus is on the care of critically ill cardiac patient (cardiogenic shock, acute myocardial infarction, complicated heart surgery and heart transplantation), rescue therapies for severe acute respiratory distress syndrome and inflammatory disorders.

Prof Dr. Seiji Kojima is Professor emeritus and prior Chairman of Department of Pediatrics and Director of the Pediatric Cancer Center at the Nagoya University Graduate School of Medicine. He is a pioneer of therapy for childhood aplastic anemia (AA) in Japan. He has been Chairperson of the Japan Childhood AA Study Group since 1992 and Chairperson of the AA Working Party of the Asia Pacific Bone Marrow Transplantation Group since 2009.

Prof. Dr. Patrick Meybohm is Director of the Department of Anaesthesiology, University Hospital Wuerzburg, Germany. Before, he was Deputy Director of the Department of Anaesthesiology, Intensive Care Medicine & Pain Therapy at the University Hospital Frankfurt. His research focus is on Patient Blood Management (preoperative anaemia, perioperative haemotherapy) and he has headed 10 studies as principal investigator and more than 40 studies as deputy investigator in clinical trials in Anaesthesiology and Intensive Care medicine.

Prof. Dr. Peter Petzelbauer is Head of Skin & Endothelium Research Division (SERD), Medical University Vienna, Austria. His research focus is on vascular barrier function in inflammation and cancer and he was the first person describing the function of peptide Bß15-42 now dubbed FX06.

Professor Dr. Roman Ullrich leads an intensive care unit in the Department of Anaesthesiology and an intensive care of the University Hospital (AKH) in Vienna, Austria, and is responsible for the management of the critical care units of the department.

Mag. Thomas Steiner, CEO and co-founder of the Austrian based F4-Pharma commented: “While the world hopes for an effective vaccine in the next months to come, COVID-19 is still growing at high pace. Further short-term development of effective therapeutics to treat severely ill patient is essential for mastering the impact of this challenging pandemic. FX06 is very well tolerated and available on short notice. All available data of FX06 outline the potential of this medication to be an effective treatment for those patients with severe disease course. Being able to put together such an outstanding, international scientific advisory board is a great distinction for us.”

Dr. Petra Wülfroth, CSO and co-founder of F4 Pharma commented: “There is emerging evidence that the virus does not only affect the lung, but also causes damage in other organs. This is due to a general inflammation of the endothelium, the inner layer of the small blood vessels. Our drug FX06 ameliorates this inflammatory process, thus reducing the often fatal consequences of the disease. F4 Pharma’s outstanding advisory board supports our endeavor to help these patients.”

Dr. Karl Nägler, Managing Partner at Munich-based venture capital firm Wellington Partners, commented: “We have provided seed financing for the further development of FX06 since we are deeply impressed by the potential benefit of FX06 in critical care in different indications. We are honored that F4-Pharma could assemble such outstanding experts for its scientific advisory board. This is invaluable for the sake of critically ill patients suffering from capillary leak and an appreciation of our investment.”

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