Drug Discovery and Development

Madrigal Pharmaceuticals expands patient access to Resmetirom trial

The company is launching a 52-week active treatment extension study that will continue making the drug available to people with non-alcoholic fatty liver disease. 

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Madrigal PharmaceuticalsLast month, Madrigal Pharmaceuticals (NSDQ:MDGL) announced promising preliminary results from an open-label Phase 3 trial from its MAESTRO-NAFLD-1 study focused on Resmetirom.

The drug, also known as MGL-3196, appeared to support reducing fat and fibrosis within the liver while also curbing biomarkers associated with inflammation. The data also suggest that the drug reduces LDL cholesterol.

Now, the company has announced a new trial known as MAESTRO-NAFLD-OLE, an open-label active treatment extension study of MAESTRO-NAFLD-1.

The new trial will enable patients who complete MAESTRO-NAFLD-1 to receive resmetirom for 52 additional weeks. Both placebo and previous resmetirom recipients will be eligible to participate.

The MAESTRO-NAFLD-1 study, which involves approximately 1,200 patients, is slated for completion before the end of 2021.

Lancet published positive data from a Phase 2 trial involving resmetirom in 2019.

Madrigal believes that Resmetirom is a first-in-class small-molecule thyroid hormone receptor, a beta-selective agonist.

Filed Under: clinical trials, Drug Discovery
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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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