FX06 to Rescue Acute Respiratory Distress Syndrome During Covid-19 Pneumonia
Status:
Completed
Trial end date:
2021-06-13
Target enrollment:
Participant gender:
Summary
Vascular leakage following endothelial injury, responsible for interstitial and alveolar
edema, is a major feature of pathogen induced acute lung injury. As acute respiratory
distress syndrome (ARDS) due to pandemic Covid-19 is associated with more than 60% mortality,
controlling vascular leakage may be a major target to decrease the mortality associated with
the spreading of the disease in France.
FX06, a drug under clinical development containing fibrin-derived peptide beta15-42, is able
to stabilize cell-cell interactions, thereby reducing vascular leak and mortality in several
animal models, particularly during lipopolysaccharide-induced and dengue hemorrhagic shock .
A phase I study was conducted in humans, with no specific adverse event detected with a dose
up to 17.5 mg/kg. In a phase II randomized multicentre double-blinded trial in 234 patients
suffering from ST+ acute coronary syndrome, FX06 treated patients exhibited a 58% decrease in
the early necrotic core zone. Importantly, adverse events were highly comparable between
groups, indicating a high safety profile for the drug . Lastly, the drug was used as a
salvage therapy in a patient exhibiting a severe ARDS following EBOLA virus infection .
Altogether, those data indicate that FX06 is well tolerated in humans and is a potent
regulator of vascular leakage.
Our hypothesis here is that FX06 may decrease pulmonary vascular hyperpermeability during
ARDS following SARS-CoV-2 infection, thereby improving gas exchanges and the outcome of
infected patients.