Low-Cost Nafamostat Blocks SARS-CoV-2 Infection in Human Lung Cells, Preclinical Study Finds

SAN DIEGO,Aug. 20,2020 --A preclinical study testing the low-cost generic drug nafamostat in human cells shows it can help block SARS-CoV-2 infection,raising excitement around Covistat's work to develop prophylactic and therapeutic COVID-19 treatments.

BiopharmaceuticalcompanyCovistat,an Ensysce Biosciences subsidiary,is repurposingnafamostat — safely used intravenously for 30 yearsas an anticoagulant and to treat pancreatitis and other diseases — into oral and inhaled COVID-19 therapies. Nafamostat works as a lock-and-key mechanism,shutting out the coronavirus bydeactivating the TMPRSS2 enzyme that enables SARS-CoV-2's spike proteins to gain entry— locking its doorway into our cells.

"This data supports nafamostat's formidable defense against the coronavirus,whether used alone or in combination with antiviral therapies that have shown promise against COVID-19," Dr. Lynn Kirkpatrick,Ensysce CEO,said. "We look forward to further studying nafamostat's ability to stop this disease's progression and help preclude people from becoming infected by SARS-CoV-2 and other seasonal coronaviruses."

The new study was completed in July by Epithelix,a world-leading independent research laboratory. Nafamostat's potent protease activity blocked SARS-CoV-2 from infecting cells in a lung cell model generated from 14 pooled donors. The model demonstrated nafamostat's safety across a wide range of concentrations with no toxicity,loss of cellular integrity or inflammatory reactions,such as potentially life-threatening cytokine storms. Using theEpithelix MucilAirplatform,the preclinical results showed nafamostat increased cilia beating — the movement of hair-like structures on the surface of cells that help sweep lungs clean of mucus and foreign objects.

Covistat has previously shown that nafamostat can be safely administered orally to healthy individuals,andthe drug is being studied by scientists as a potential antiviral therapy. To help rapidly move into clinical studies,Covistat recently acquired technology and intellectual property from London-based Mucokinetica,known for its decades of research,deep technical expertise and patented technology in inhaled and intranasal administration of nafamostat. Compared to intravenous treatments,oral,inhaled and intranasal drugs often are significantly less costly and highly accessible to more people in the U.S. and around the world.

MEDIA CONTACT:Drive West Communications,Covistat@DriveWest.com,281.220.6861 ext. 704

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