F4 Pharma’s FX06 shows promising results in critically ill COVID-19 patients

MChE / F4 Pharma and SIRS therapeutics announce promising results from treatment of six severely ill COVID-19 patients with FX06 under “named patient use”. By time of start of FX06 administration, all patients were treated in the ICU with mechanical ventilation, and five - in addition - received extracorporeal membrane oxygenation (ECMO). Within a few days following the FX06 treatment, all patients showed an improvement of lung function parameters and a significant reduction of inflammation markers. The effect may be attributed to the drug’s potent anti-inflammatory properties and its ability to reduce capillary leak and edema formation.

Dr. Petra Wülfroth, CSO and cofounder of the Austrian Vienna-based Biotech F4 Pharma stated: “Given the severity of the disease and the poor prognosis of these patients, the favorable clinical response observed in all patients, resulting in the survival of four out of six patients, exceeded our expectations. We believe that the use of FX06 in severe cases of COVID-19 associated with ARDS and endotheliitis could be an effective therapy to improve the disease course of the patients needing mechanical ventilation and ECMO. These first results in named patient use settings are to be confirmed in upcoming clinical trials.”

Mag. Thomas Steiner, CEO and co-founder of F4 Pharma, stated: “Anti-viral substances have shown interesting results in early stages of COVID-19, however their merits in the treatment of severely ill patients have still not been proven. Immunosuppressive strategies such as IL-6 antagonists or steroids have shown some results lately. The results obtained in named patient use applications with FX06 are indicating that our substance could become an important component in the therapy of severely ill COVID-19 patients, complementing anti-viral strategies or specific immunosuppressive medication.  Results of named patient use treatments call for confirmation in controlled clinical trials. We have filed for authorization with ethical committees last week and look forward to the clinical studies being prepared at renowned European clinical centers.”  

Dr. Rainer Strohmenger, Managing Partner at Munich-based venture capital firm Wellington Partners, commented: “We have decided to financially support the clinical development of FX06, because we are convinced that this drug candidate can be of benefit for patients in a variety of severe clinical conditions associated with system inflammation and vascular leakage. In our opinion, the promising results from first compassionate use in COVID-19 patients are confirming this hypothesis.”  

FX06 is a naturally occurring peptide, Bβ15-42, derived from the E1 fragment of fibrin. The mechanism of action of FX06 is an important new discovery in understanding acute inflammation and edema formation. Based on animal models of vascular leakage and systemic inflammation, FX06 has considerable therapeutic potential for all diseases and pathological conditions associated with increased vascular permeability and inflammation of the endothelium i.e. the inner layer of blood vessels.

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