Adamis Pharmaceuticals (NASDAQ:ADMP) said Wednesday that the company’s experimental COVID-19 therapy Tempol did not achieve the primary endpoint in a Phase 2/3 clinical trial that involved high-risk subjects with early COVID-19 infection.
The study, designed to enroll about 248 adults, evaluated an 800mg daily dose of Tempol for up to 21 days delivered in two divided oral doses of 400mg capsules.
Its third interim analysis indicated that the study did not reach the primary endpoint, as measured by the sustained clinical resolution of COVID-19 symptoms at day 14 for Tempol compared to placebo.
The trial’s independent Data Safety Monitoring Board identified no safety concerns for the experimental therapy. However, based on its recommendation, the company has decided to halt the study and evaluate the data to determine the next steps for the Tempol development program.
“We will continue to analyze the data to determine if we believe Tempol can be utilized in other COVID patient populations including those with more severe illness or immunocompromised,” ADMP medical chief Ron Moss said.
Read: ADMP shares surged in Jun. 2021 after the U.S. National Institute of Health (NIH) indicated the potential of Tempol as an oral antiviral therapy against COVID-19.