- Lexicon Pharmaceuticals (NASDAQ:LXRX +3.8%) is up on below-average volume in reaction to its announcement that the first patient has been dosed in a Phase 2a clinical trial, TELE-ABC, evaluating XERMELO (telotristat ethyl) in patients with biliary tract cancer.
- The open-label 54-subject study is assessing telotristat ethyl, combined first-line chemo (cisplatin + gemcitabine), in patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy in the locally advanced or metastatic setting. The primary efficacy endpoint is progression-free survival (PFS) at month 6.
- Topline data should be available in 2020.
- Telotristat ethyl inhibits an enzyme called tryptophan hydroxylase that plays a key role in controlling the production of excess serotonin, a chemical that stimulates aggressive cancers and carcinoids.
- The FDA approved XERMELO in February 2017 for carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors who are inadequately controlled with somatostatin analog therapy.