SAN DIEGO--(BUSINESS WIRE)--Ensysce Biosciences announced that it is exploring the opportunity to initiate a clinical trial of oral Nafamostat, an ingredient from its opioid overdose protection platform, as a treatment for COVID-19. The goal is to evaluate if nafamostat mesylate (Nafamostat), a synthetic protease inhibitor will be effective in preventing or reducing the lethal outcome of COVID-19 infection.
Currently, there are no approved drugs to manage infection with SARS-CoV-2 and nafamostat has shown promise in several studies against Middle East Respiratory Syndrome (MERS) and more recently SARS-CoV-2. Nafamostat was found to be a potent inhibitor that blocks the viral entry into host cells. Ensysce is planning a Phase 1/2 trial to examine an oral solution of nafamostat, a route of administration that has not been explored for this drug.
Ensysce is reviewing its data from a prior clinical trial in Australia that evaluated nafamostat orally. Ensysce has a safety package prepared and has requested Emergency Use Authorization from the FDA to move into a trial with oral nafamostat in the United States.
Ensysce Biosciences has interest of clinical sites in the Texas Medical Center. Additionally, there is strong interest from other major medical centers in Europe and Asia to conduct other trials in those jurisdictions.
Nafamostat has been approved for intravenous use in Japan for pancreatitis and other diseases, signifying assurance in the drug’s safety and the potential for a quick move to clinical trials. A clinical trial to evaluate intravenous nafamostat is being initiated in April by the University of Tokyo in Japan.
Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences, said, “We are committed to getting this oral study running as fast as possible. We have previously shown that nafamostat can be safely administered orally to healthy subjects, and this data allows us to explore the beneficial effects of nafamostat in those individuals who are experiencing symptoms related to COVID-19. We are very happy to be able with work with international medical sites to quickly initiate this potentially lifesaving study and are keen to start a similar trial in the US as soon as possible.”
“Finding a safe and effective treatment to address SARS-CoV-2 is a pressing health priority,” said Dr. William Schmidt, Chief Medical Officer of Ensysce. “This study will be an important step toward achieving that goal.”
About Ensysce Biosciences and the Opioid crisis.
Ensysce Biosciences is developing a new class of opioid pain products (Trypsin Activated Abuse Protected – TAAP) which could deliver the first non-abusable opioid. A second drug class designed to avoid the risk of deliberate or accidental opioid overdose, called Multi Pill Abuse Protection (MPAR) is also in development. MPAR uses nafamostat to limit dosing of TAAP products, possibly creating first “overdose proof” opioid. These development programs are being partially funded by the US government NIH and NIDA, and the first TAAP agent, PF614 has been granted FDA fast-track approval status.
More information at ensysce.com