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EMD Serono’s IND Cleared for M5049 for Covid-19 Pneumonia

Will initiate a Phase II randomized trial evaluating the safety and efficacy of M5049 in Covid-19 pneumonia.

By: Contract Pharma

Contract Pharma Staff

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.”

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