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Vienna, June 24, 2020

Press Release MCHE / F4 Pharma and SIRS therapeutics

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.

Contact:
     
MChE /F4-Pharma

Business:
Mag.Thomas Steiner
Tel +43 6641107694

Science:
Dr. Petra Wülfroth  
F4 Pharma GmbH i.G.  
Mobile +41 79 788 1800

Wellington Partners

Dr. Rainer Strohmenger, Managing Partner  
Via Ulrike Hartl
+49 (0) 89 219941-20

 


 
Vienna, April 15, 2020

Press Release MCHE / F4 Pharma
Financing / Covid-19

FX06 treatment for severely ill patients

MChE / F4-Pharma, an Austrian clinical stage biopharmaceutical company, has received financing from Wellington Partners, a leading European venture capital firm investing in early and growth stage life  science companies, via its newly-founded portfolio company SIRS Therapeutics, Munich Germany.

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."

Contact details:

MChE / F4-Pharma
Business:
Mag. Thomas Steiner,
thomas.steiner@f4-pharma.com,  Tel.: +43 6641107694

Science:
Dr. Petra Wülfroth
F4 Pharma GmbH i.G.
petra.wuelfroth@f4-pharma.com, Mobile: +41 79 788 1800

Wellington Partners
Dr. Rainer Strohmenger, Managing Partner via Ulrike Hartl hartl@wellington-partners.com, Tel.: +49 (0) 89 219941-20




Wien, 15. April 2020
Presse Aussendung MCHE / F4 Pharma
Finanzierung / Covid-19

FX06 Behandlung schwer erkrankter Patienten

Bereits im Heilversuch bei einem Ebola Patienten eingesetzt, hat die im Wiener AKH entdeckte Substanz FX06 das Potenzial, schwer erkrankten Covid-19 Patienten zu helfen. Eine Finanzierung durch den Venture Capital Fonds Wellington Partners ermöglicht nun den Eintritt in klinische Studien.

Von Professor Peter Petzelbauer am Wiener AKH entdeckt, hat die Substanz FX06 in zahlreichen wissenschaftlichen Studien ihre Wirksamkeit an Tiermodellen nachgewiesen. In einer Studie mit 236 Patienten mit Herzinfarkt wurde die gute Verträglichkeit von FX06 gezeigt und die klinische Wirksamkeit der Substanz zur Verhinderung von entzündlichen Gewebsschädigungen (Reperfusionssyndrom) nachgewiesen.

FX06 ist weder der ersehnte Covid-19 Impfstoff noch eine anti-virale Substanz, sondern soll zur Behandlung schwer erkrankter Covid-19 Patienten mit generalisierten Entzündungsreaktionen eingesetzt werden. ARDS, Sepsis und septischer Schock gehören zu den lebensbedrohlichen Komplikationen, deren Auswirkungen es zu bekämpfen gilt. Genau das tut FX06, indem es den sogenannten "Capillary Leak" bekämpft. Damit bezeichnet man einen Zustand, bei dem die kleinsten Blutgefäße, die Kapillaren, aufgrund der heftigen Abwehrreaktion des Immunsystems gegen den Virus "löcherig" werden, und zu viel Flüssigkeit und Entzündungszellen aus dem Blut ins Gewebe gelangen. In der Lunge kommt es dadurch zur Ödembildung und zur Behinderung des Sauerstoffaustausches.

Während der vorangegangenen Ebola-Krise in West-Afrika wurde ein an Ebola erkrankter ugandischer Kinderarzt – er hatte sich bei einer Geburtshilfe infiziert – an die Universitätsklinik Frankfurt evakuiert. Er musste bald künstlich beatmet werden und war in einem lebensbedrohlichen Zustand. Ein Frankfurter Team um Professor Dr. Dr. Kai Zacharowski setzte FX06 zu seiner Behandlung ein und konnte die Lungenfunktion des Patienten verbessern. Der Patient wurde gerettet und hat sich wieder vollständig erholt.

Aufgrund der Ergebnisse dieses Heilversuches und der zahlreichen positiven klinischen und präklinischen Untersuchungen geht F4-Pharma, ein österreichisches Start-up Unternehmen, davon aus, dass FX06 schwer erkrankten Covid-19 Patienten helfen und viele Leben retten könnte. Bereits vorhandene FX06-Substanz soll daher für die klinische Erprobung an Zentren in Europa zur Verfügung gestellt werden.

Dank einer Finanzierung durch den Münchner Venture Capital Fonds Wellington Partners können die Vorbereitungen für klinische Studien in Wien, Paris, Frankfurt und Würzburg getroffen werden. Alle betroffenen Kliniken behandeln bereits schwer erkrankte Covid-19 Patienten und arbeiten gemeinsam mit der F4-Pharma an der Entwicklung des klinischen Protokolls. Die weitere klinische Entwicklung von FX06 wird jedoch die finanziellen Möglichkeiten von F4-Pharma weit übersteigen.

Ohne den erklärten Willen der österreichischen Bundesregierung, die Entwicklung von Therapieverfahren und die Planung und Durchführung von klinischen Studien im Rahmen des FFG Emergency Calls zur Erforschung von Covid-19 zu fördern, wäre es schwierig, das Potential des österreichischen Standortes für die Bekämpfung der Covid-19 Krise auszuschöpfen.

Mag. Thomas Steiner, Geschäftsführer der MChE / F4-Pharma meint dazu: "Covid-19 ist nicht die einzige Indikation, bei der FX06 einen wichtigen therapeutischen Beitrag leisten kann. Wir haben  großartige Forscher und Kliniker in Österreich. Die staatliche Unterstützung unserer klinischen Studien ist ein wichtiger und richtiger Schritt."

Dr. Rainer Strohmenger, Managing Partner bei Wellington Partners, ergänzt: "Wir glauben fest an das Potenzial von FX06 in der intensivmedizinischen Behandlung von Covid-19 Patienten. Die bisherige Datenlage und der gut erforschte Wirkmechanismus der Substanz lassen darauf hoffen, dass FX06 einen wichtigen Beitrag zur Rettung vieler Patienten mit Lungenversagen leisten kann. Gleichzeitig hat sich FX06 bereits als sehr gut verträglicher Wirkstoff erwiesen."

MChE /F4-Pharma

Zum Unternehmen:
Mag. Thomas Steiner,
thomas.steiner@f4-pharma.com, Tel +43 6641107694

Zur Wissenschaft:
Dr. Petra Wülfroth
F4 Pharma GmbH i.G.,
petra.wuelfroth@f4-pharma.com, Mobile +41 79 788 1800

Wellington Partners
Dr. Rainer Strohmenger, Managing Partner via Ulrike Hartl, hartl@wellington-partners.com Tel +49 (0) 89 219941-20




December 19, 2014:

Paper about FX06 in The Lancet: Doctor who survived Ebola received experimental drug treatment [read]

Bloomberg report: Ebola Doctor’s Recovery Shows Promise of Resurrected Lung Drug [read]



November 10, 2014 – Press release:

F4 Pharma’s developmental drug FX06 successful in treating vascular leak in Ebola

First highly encouraging results in treating an Ebola infected patient in Frankfurt with FX06

The University Hospital in Frankfurt reported the successful treatment of an Ebola patient medically evacuated from Sierra Leon. The compound FX06, developed in Austria, was used by experts of the University Hospital in Frankfurt under compassionate use after approval by the ethic committee. FX06 could substantially contribute to the recovery of the patient. The substance had been developed by a scientist at the Vienna General Hospital (AKH) and has the potential to decisively influence the outcome of an Ebola infection.

"Originally we wanted to focus on another indication and were in the course of raising funds when we realized that all our preclinical and clinical data of FX06 are addressing principally one of the most dramatic disease patterns of Ebola, the so-called ‘vascular leak’. FX06 is sealing the walls of the blood vessels which become leaky during the disease course with the consequence of severe and irreparable damage of vital organs like kidney, liver and lung." This can be life saving" declares Mr. Thomas Steiner. The Viennese entrepreneur is CEO of the company MChE F4-Pharma.
"We had already been in contact with the WHO and other international organizations when we received the request from Frankfurt. Fortunately the manufacturer of our substance, Bachem, was able to deliver FX06 immediately and in an un-bureaucratic procedure to Frankfurt."

"We actually created the prerequisites for further compassionate use in Europe and our drug is stored centrally at the  University of Frankfurt. Now the challenge is to overcome any arising further regulatory documentations before we can start a clinical trial in West Africa” states the biotechnical expert Dr. Petra Wülfroth of F4-Pharma.

The cooperation with the team at the University Hospital in Frankfurt, headed by Prof. Dr. Kai Zacharowski, is a cardinal point to facilitate the use of FX06 in specialized centers in Europe and also in West Africa at the earliest convenience. The scientific research performed in intensive care units in European and US are prerequisites to understand the course of this striking epidemic.

"As a matter of fact MChE F4-Pharma is in urgent need of support and is looking for further funds. We hope to be able to count on investors of the public and private sector in order to have FX06 ready as soon as possible against Ebola world-wide" concludes Mr. Steiner. The manufacturer of FX06, Bachem, already donated material in the value of several 100.000 Euro.




November 6, 2014:

Peptide FX06 has been applied in the medication of an Ebola patient in Frankfurt.
Below you find some press reports on this topic:

  • t-online - Nov 5, 2014: Uniklinik Frankfurt setzt neuen Wirkstoff gegen Ebola ein [read]
  • Reuters - Nov 5, 2014: German doctors use experimental heart drug in treating Ebola patient [read]
  • vienna online - Nov 5, 2014: Die Entwicklung des möglichen Ebola-Medikaments FX06 [read]
  • Wiener Zeitung- Nov 5, 2014: Wiener Arznei half in Frankfurt bei Ebola [read]
  • vienna online - Nov 5, 2014: Ebola – Medikament kommt aus Wien: Erster Patient mit FX06 behandelt [read]
  • Kronen Zeitung - Nov 5, 2014: Wiener Medikament neue Hoffnung gegen Ebola [read]

   

F4 Pharma GmbH i.G. - © 2020
Page modified: June 24, 2020
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