Inflammatory Bowel Disease (IBD)

Targeting FXR represents a novel approach to treating Inflammatory Bowel Disease, or IBD. In addition to NASH, we plan to develop our FXR product candidates as potential first-in-class treatments for IBD, including Ulcerative Colitis, or UC, and Crohn’s disease. Patients with IBD can suffer from abdominal pain and bloody diarrhea and have increased risk of colorectal cancer. The global incidence of IBD is increasing and, as of 2015, it was estimated that there were 3.1 million people in the United States with IBD. Injectable biologics are commonly used to treat patients with moderate-to-severe IBD, and while these biologic agents can be effective initially, they increase the risk of opportunistic infections and can be challenging to administer.

We believe an oral, once-daily therapy with FXR agonists could be anattractive treatment option for UC patients that may prefer oral administration instead of injectable biologics that are cumbersome to administer chronically. In preclinical studies of our FXR agonists, we have observed improvement in colon inflammation on a level similar to that of injectable biologics currently used for treatment. We intend to submit an investigational new drug application, or IND, for either MET409 or MET642 in the first half of 2022 and initiate a Phase 2a proof-of concept clinical trial for the treatment of UC in the first half of 2022 after data from our clinical trials in healthy volunteers and NASH is available. Such data will be used to help inform our Phase 2a clinical trial for the treatment of UC.