26 June 2020 - - US-based EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada,

The US Food and Drug Administration has cleared US-based EMD Serono's investigational new drug application for M5049 for the treatment of patients with Covid-19 pneumonia, the company said.

US-based EMD Serono is the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada.


The company will initiate a Phase II randomized, controlled clinical study 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 7 and TLR8, two innate immune sensors that detect single-stranded RNA from viruses such as SARS-CoV-2, the virus responsible for Covid-19.

Activation of TLR7/8 leads to immune cell activation and inflammation, which when not properly controlled can cause severe immunopathology.

The aim of the study is to investigate if M5049 intervention at a critical point in the course of Covid-19 disease may 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.

M5049 will be investigated in a randomized, placebo-controlled study at sites in the United States and Brazil. In addition to standard of care, which may include antiviral treatments, subjects will receive one of two doses of M5049 or placebo with the intent of comparing M5049 to placebo based on patient outcomes.

Approximately 150 subjects will be randomized into one of the three treatment arms. In addition to the FDA, Merck KGaA, Darmstadt, Germany is working with other global health authorities and investigators to accelerate clinical development to meet the critical need presented by the current global pandemic and expects results from the Phase II study around the end of 2020.

M5049 was discovered in-house at Merck KGaA, Darmstadt, Germany and recently completed a Phase I study in healthy volunteers. The company is evaluating M5049 in immunology indications in addition to a potential therapeutic intervention against Covid-19.

This Phase II study complements the existing response from the company to the Covid-19 pandemic, which also includes in-kind contributions, product donations, resources, and expertise in consortia and partnerships aimed at fighting this Covid-19 pandemic.

EMD Serono is dedicated to serving patients, scientists and customers during this time for more information on the response, please.

EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada - is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases.

The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients.

Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS.

Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. 

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials.