The Woodlands, Texas, December 3, 2019 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today the completion of a safety review of the initial run-in cohort of the Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, which is a Phase 2 clinical study of telotristat ethyl in patients with biliary tract cancer. Telotristat 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.”
About the TELE-ABC Study
The TELE-ABC study is a multicenter, open-label, two-stage Phase 2 study evaluating the safety and efficacy of telotristat ethyl in combination with standard of care, first-line chemotherapy (cisplatin plus gemcitabine) in approximately 53 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 results on 6-month progression-free survival data from the first 20 patients of the TELE-ABC study in 2020.
About XERMELO (Telotristat Ethyl)
Discovered using Lexicon’s unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells.
XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.
Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.
XERMELO (Telotristat Ethyl) Important Safety Information
- Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
- Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
- Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.
For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.
About Lexicon Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), sotagliflozin and LX9211. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin and LX9211 and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2018, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
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