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Lexicon Pharmaceuticals Announces Dosing of First Patient in TELE-ABC Study
Mar. 15, 2019 09:03AM PST
Pharmaceutical InvestingLexicon Pharmaceuticals (NASDAQ:LXRX) has announced the dosing of the first patient in the Telotristat Ethyl for Advanced Biliary Tract Cancer (TELE-ABC) in a Phase2a clinical study of telotristat ethyl in patients with biliary tract cancer. As quoted in the press release: Telotristat ethyl (XERMELO®) is a novel, oral tryptophan hydroxylase (TPH) inhibitor that has been …
Lexicon Pharmaceuticals (NASDAQ:LXRX) has announced the dosing of the first patient in the Telotristat Ethyl for Advanced Biliary Tract Cancer (TELE-ABC) in a Phase2a clinical study of telotristat ethyl in patients with biliary tract cancer.
As quoted in the press release:
Telotristat ethyl (XERMELO®) is a novel, oral tryptophan hydroxylase (TPH) inhibitor that has been approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy alone.
“With our ongoing commitment to bring innovative therapies to patients with debilitating diseases, we are pleased to advance telotristat ethyl into a proof-of-concept study in patients with biliary tract cancer,” said Praveen Tyle, Ph.D., executive vice president of research and development. “We believe this is an important opportunity to explore telotristat ethyl’s potential outside of carcinoid syndrome diarrhea based on the drug’s mechanism of action and on the critical role serotonin plays in regulating several major physiological processes, including cell proliferation. Initiation of the TELE-ABC study is an important next step in our plan to expand the number and types of patients who may benefit from telotristat ethyl.”
About the TELE-ABC Study
The TELE-ABC study is a multicenter, open-label, two-stage Phase 2a study evaluating the safety and efficacy of telotristat ethyl in combination with standard of care, first-line chemotherapy (cisplatin plus gemcitabine) in approximately 54 patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer. The primary efficacy endpoint under evaluation is progression-free survival (PFS) rate at six months. Secondary endpoints include overall survival (OS), OS rate at six and 12 months, and PFS rate at 12 months.
Subject to completion of patient enrollment, Lexicon expects to report topline initial cohort data from the TELE-ABC study in 2020.
