The company has announced it has completed the safety of an initial run-in cohort of its TELE-ABC Phase 2 clinical study.
Lexicon Pharmaceuticals (NASDAQ:LXRX) has announced it has completed the safety of an initial run-in cohort of its Telotristat Ethyl for Advanced Biliary Tract Cancer — the TELE-ABC study — which is a Phase 2 study of telotristat ethyl in patients with biliary tract cancer.
As quoted in the press release:
elotristat ethyl is a novel, oral tryptophan hydroxylase (TPH) inhibitor approved as XERMELO® for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy alone.
Safety analysis from the first six patients who completed at least a 21-day cycle of treatment with telotristat ethyl in combination with cisplatin and gemcitabine supports the continuation of enrollment with no adjustment in the telotristat ethyl 500 mg three times daily dosing. To date, the first two patients enrolled have completed over six months of treatment.
“We are pleased that the safety review of the first dose cohort supports continuation of the study in patients with biliary tract cancer,” said Pablo Lapuerta, MD, executive vice president and chief medical officer of Lexicon. “We believe telotristat ethyl’s mechanism of action has potential utility outside of carcinoid syndrome diarrhea. Inhibiting serotonin may help control tumor growth, and we look forward to obtaining topline data on progression-free survival for the first 20 biliary tract cancer patients next year.”