EMD Serono, the biopharmaceutical business of Merck KGaA, received clearance from U.S. FDA for its investigational new drug application (IND) for M5049 for the treatment of patients with Covid-19 pneumonia. The company will initiate a Phase II randomized trial evaluating the safety and efficacy of M5049 in this patient population. M5049 is a potentially first-in-class small molecule that blocks the activation of Toll-like receptor (TLR)7 and TLR8, two innate immune sensors that detect single-stranded (ss) RNA from viruses such as SARS-CoV-2. Activation of TLR7/8 leads to immune cell activation and inflammation, which when not properly controlled can cause severe immunopathology.

The study aims to investigate if M5049 intervention at a critical point in the course of Covid-19 disease can prevent or ameliorate the hyper-inflammatory response in patients with Covid-19 pneumonia and prevent progression to ‘cytokine storm’. Successful intervention with the investigational drug may reduce life-threatening complications of Covid-19, including severe respiratory symptoms that often necessitate further medical interventions such as mechanical ventilation.

“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,” said Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck KGaA, Darmstadt, Germany. “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.”