Yale School of Medicine and the biopharmaceutical firm AI Therapeutics have launched a multi-institutional clinical trial of a drug for treating COVID-19.
Known as LAM-002A (apilimod), the drug has a proven safety record. Preliminary research has shown it can block cellular entry and trafficking of the SARS-CoV-2 virus, the cause of COVID-19.
Previous trials involving more than 700 patients have shown LAM-002A to be safe for the treatment for autoimmune diseases and follicular lymphoma. The drug has received Fast Track Status and Orphan Drug Designation from the Food & Drug Administration for treatment of lymphoma.
The Yale Center for Clinical Investigation is now enrolling patients in a Phase II trial for the drug's use as a COVID-19 treatment. The study is expected to enroll 142 newly diagnosed patients to test the safety and efficacy of the drug in reducing virus levels in infected individuals.
AI Therapeutics, a Guilford, Conn.-based biopharmaceutical company formed by Yale alumnus Jonathan Rothberg, owns intellectual property rights to the drug.
A multi-institutional study published in Nature, which screened more than 13,000 existing drugs against two strains of the live SARS-CoV-2 virus, found LAM-002A to be the most effective in combatting the virus, including in lung cells infected with the virus. In another study in the journal Cell, another group of researchers independently showed that LAM-002A could combat SARS-CoV-2 infections in human lung cells.
AI Therapeutics' unpublished data along with data recently published by the Scripps Research Institute suggest that LAM-002A administered with remdesivir, already approved for treating COVID-19, can boost the effectiveness of the antiviral agent.
"LAM-002A holds promise to be a powerful new therapy for COVID-19 patients to prevent progression of disease, hopefully avoiding the need for hospitalization" said Yale's Murat Gunel, professor of neurosurgery and professor of genetics and neuroscience. Gunel serves as the chief scientific adviser to AI Therapeutics and has a financial interest in the company.
Gunel noted that if LAM-002A shows effectiveness in this phase, the trial could be expanded to assess whether it would help prevent the development of disease after exposure, particularly in high-risk populations, such as the elderly in nursing homes, health care and frontline workers, or people in underserved communities.
Charles S. Dela Cruz, associate professor of medicine and microbial pathogenesis and director of the Center for Pulmonary Infection Research at Yale University, will lead the study. Institutions in other areas of the country are expected to enroll patients soon.
"We are delighted to be partnering with AI Therapeutics to see if LAM-002A can help ameliorate the devastating impact of this coronavirus pandemic on our society," Dela Cruz said.