“At Home Coronavirus Pill” to Advance to Phase 2 Clinical Development

Ensysce Biosciences, Inc. announced that Ensysce’s subsidiary, Covistat, will be presenting at the upcoming American Thoracic Society (ATS) Annual Meeting to be held May 14-19, 2021. ATS 2021 showcases the latest advances and discoveries in respiratory science, patient care and global respiratory health.

Covistat will present a summary of its findings that it believes demonstrate the ability of nafamostat, delivered to airways, to inhibit SARS-CoV-2 viral infection and increase mucocilliary clearance in the human airway, in a poster presentation entitled “Nafamostat inhibits SARS-CoV-2 Infection and ENaC activity in Human Airway Epithelial Cells.” The authors of the presentation are Lynn Kirkpatrick, Jeffrey Millard, Rod Hall, Peter Cole & Samuel Constant; Covistat, San Diego & Epithelix, Geneva, Switzerland. Nafamostat is part of a class of medicines called protease inhibitors which works by inhibiting an enzyme that the SARS-CoV-2 virus requires to replicate in human cells.

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce commented, “Our primary mission is to change analgesic care, but when we became aware that nafamostat appeared to have utility against coronaviruses, we quickly commenced clinical studies with our oral formulation. This agent has been widely used intravenously in Asia on a safe and effective basis, and we believe it will have great utility in an outpatient setting at low cost and through use as an adjunct to vaccines, or where vaccines cannot be readily accessed. We completed our Phase 1 trial with oral nafamostat in November of 2020 and now are progressing to Phase 2 in COVID-19 patients that are not hospitalized yet are without therapeutic options.”

“We believe nafamostat, taken by mouth, could dramatically change treatment options because people newly infected with the virus may be able use it outside of hospitals. Our current expectation is that the medication could keep the disease from progressing and prevent unnecessary hospitalizations,” Dr. Kirkpatrick concluded.

Nafamostat is also a component of Ensysce’s multi-pill abuse resistance (MPAR™) platform that is poised to enter a Phase 1 trial, a major clinical milestone for the protection of opioid overdose. Ensysce has intellectual property which it believes protects the use of nafamostat for overdose protection of prescription drugs and for use to treat Cystic Fibrosis. Covistat is currently exploring the use of oral nafamostat for treatment of COVID-19 and expected to launch a Phase 2 trial during the second half of 2021.