Potential COVID-19 treatment LAM-002A to enter Phase II clinical trial
Yale University and AI Therapeutics will collaborate on a Phase II trial to study LAM-002A as a COVID-19 treatment for newly diagnosed patients.
Yale University and AI Therapeutics have announced the start of a Phase II clinical trial to study LAM-002A as a treatment for newly diagnosed COVID-19 patients. The randomised, double-blind, placebo-controlled study (NCT04446377) will enrol up to 142 outpatients to evaluate the safety, tolerability and efficacy of LAM-002A in reducing viral load in subjects with a confirmed COVID-19. Additional measures of clinical efficacy will be evaluated, including death, hospitalisation and oxygen saturation.
According to the researchers, LAM-002A is a first in class, highly selective PIKfyve kinase inhibitor that has demonstrated potent in vitro antiviral activity against several isolates of SARS-CoV-2, the virus responsible for COVID-19 and several studies now have shown that LAM-002A interferes with the entry and trafficking of the SARS-CoV-2 virus in cells. Given its mechanism of action, LAM-002 also has the potential to become part of combination therapies, especially with other drugs that target viral proteins or functions, such as viral replication, say the researchers.
Dr Murat Gunel, Chair of Neurosurgery and Professor of Neurosurgery, Genetics and Neuroscience at Yale University stated: “LAM-002A’s safety has been demonstrated in more than 700 healthy subjects and patients with inflammatory and malignant conditions. It is one of the most potent drugs in pre-clinical tests against SARS-CoV-2. Its safety profile and effectiveness provide a strong rationale for urgently evaluating this drug in COVID-19 patients, who have few options to slow the progression of the disease.”
AI Therapeutics has announced that to make LAM-002 accessible, it has 70,000 doses ready to go, 70,000 currently going through production and the compound in preparation for nearly five million more doses.
“We all want to do our part to allow the people we love to get back to work, school and play. At AI Therapeutics we feel we need to do all we can to make sure our drug, LAM-002, has the best shot to help and working with Yale is the perfect place to start,” said Jonathan Rothberg, AI Therapeutics’ co-founder.