The FDA has cleared Merck’s IND for M5049 as a treatment option for Covid-19 pneumonia. A Phase II study will now begin to evaluate the safety and efficacy of M5049. Their novel compound is a small molecule that blocks the activation of TLR7 and TLR8, two innate immune sensors that detect ssRNA from viruses (like SARS-CoV-2). Activation of TLR7 and TLR8 leads to immune activation and inflammation. Uncontrolled immune activation is the main cause of severe immunopathology and cytokine storm formation.
Belén Garijo, CEO Healthcare and Executive Board Member of Merck, said, "At Merck, we have a clear priority to identify potential solutions across the full spectrum of the COVID-19 pandemic, including prevention, symptom management, severe infection and recovery". Belén continued, "With M5049, we aim to study a novel approach to treating severe complications of COVID-19 that we hypothesize could translate to other single-stranded RNA viruses including other coronaviruses."
M5049 was discovered at Merck and recently completed a successful Phase I study in healthy volunteers. In addition to the therapeutic potential against COVID-19, Merck is evaluating M5049 in immunology indications.