【Breaking News!】 First MASH treatment approved by FDA
On March 14th, The United States Food and Drug Administration (FDA) announced their approval of Rezdiffra (resmetirom), developed by Madrigal Pharmaceuticals, as the first treatment for MASH.
► FDA NEWS RELEASE FDA approved first MASH treatment
It took more than 15 years for Rezdiffra to be approved for the treatment of MASH, and the development of other companies' candidates has been difficult during that time. Furthermore, although Rezdiffra has been approved, clinical trial results indicate that at least half of MASH patients did not show any improvement in their condition. These problems are thought to be due to the complexity of the MASH disease mechanism, which is one of the reasons why therapeutic drug development has not previously been successful. This approval is expected to heat up the market for the development of MASH drugs.
Our STAM™ mouse reflects the complex pathology that occurs in MASH.
Compounds in various pathways, including lipid metabolism, including Rezdiffra's target, THR-β, as well as glucose metabolism, inflammation, and fibrosis, have been evaluated in this model, and many compounds have advanced to clinical trials.
The STAM™ mouse is a model of MASH, fibrosis, and hepatocarcinoma in a background of fatty liver and can evaluate these diseases through improvement of lipid metabolism, which is the MOA of Rezdiffra. Therefore, this model can be used to evaluate the test substance as well as the therapeutic effect of combined administration with Rezdiffra.
With our expertise and experience conducting more than 800 drug efficacy evaluation studies using our STAM™ mouse, we are confident that we can propose optimal suggestions to match your needs.
If you have any questions or requests for more information, please feel free to contact us.