FX06 is a platform molecule with a novel mode of action. FX06 binds to the so-called adherence junctions between the endothelial cells which are forming the inner layer of blood vessels. In doing so, the drug preserves the integrity of the endothelium and prevents the leakage of fluid from the blood vessel into the surrounding tissue. In addition FX06 also has anti-inflammatory properties. The drug was already investigated in another – mechanistically related indication – and has demonstrated convincing efficacy in a clinical study with 236 patients. FX06 was very well tolerated and exhibited a benign safety profile.
In early 2020, Sars-CoV-2 (COVID-19) represents, after MERS and SARS, the third epidemic caused by coronaviruses in the 21st century. To date, SARS-CoV2 has evolved to a global pandemic with +2,000,000 confirmed cases and +120,000 deaths in + 180 countries, numbers in most countries still growing exponentially. In general, most COVID-19 patients experience mild to moderate symptoms including fever, cough, dyspnoea, taste disturbances or muscle pain. However, thoracic x-rays of some patients present bilateral infiltrations known from interstitial pneumonia. Critically ill patients, which constitute 2-9% of all infected, progress from first symptoms and diagnosis to hypoxia and pneumonia and can reach life threatening ARDS, for which acute treatment options are scarce.
FX06 has the potential to become an effective novel therapeutic for treatment of severely ill Covid-19 patients: SIRS and F4-Pharma - joint owners of all rights to FX06 - have initiated final steps of GMP production for the drug material and are planning and preparing for a multi-center clinical study in Vienna, Frankfurt and Würzburg. Further clinical centers might be included in the trials.
Thomas Steiner, CEO of MChE/F4 Pharma, and Co-founder Dr. Petra Wülfroth explained: „Based on our knowledge and expertise we are convinced that FX06 can help severely ill Covid-19 patients. We are extremely pleased having gained the support of Wellington Partners for the development of FX06 in severely infected COVID-19 patients. Our mission is to make FX06 available for clinical testing in this indication of highest unmet medical need within the next couple of weeks. Our hope is that patients may respond to FX06 treatment in a similar favorable way as it was shown under compassionate use during the 2014 outbreak of Ebola in a case study published in Lancet.
Dr. Rainer Strohmenger, Managing Partner of Wellington Partners, commented: “We believe that FX06 could provide immediate value in the treatment of critically ill COVID-19 patients with impaired lung function, sepsis and ARDS. The investment into SIRS Therapeutics has been made to accelerate the clinical development of this compound, which has already proven to be safe with strong hints for clinical efficacy in related pathologies on the basis of a well understood mechanism of action.”
Tel +43 6641107694
Dr. Petra Wülfroth
F4 Pharma GmbH i.G.
Mobile +41 79 788 1800
Dr. Rainer Strohmenger, Managing Partner
Via Ulrike Hartl
+49 (0) 89 219941-20