The Woodlands, Texas, March 15, 2019 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today dosing of the first patient in the Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, which is a Phase 2a clinical study of telotristat ethyl in patients with biliary tract cancer. 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.
About XERMELO (Telotristat Ethyl)
Discovered using Lexicon’s unique approach to gene science, telotristat ethyl is the first and only approved oral therapy for carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSAs. Telotristat ethyl targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. Lexicon has built the in-house capability and infrastructure to market telotristat ethyl for carcinoid syndrome diarrhea in the U.S., where it retains all commercialization rights. Lexicon also retains rights to market telotristat ethyl in Japan. Lexicon has established a license and collaboration agreement with Ipsen to commercialize telotristat ethyl in Europe and other countries outside of U.S. and Japan.
Telotristat ethyl was approved by the U.S. Food and Drug Administration on February 28, 2017 and by the European Commission on September 19, 2017 for the treatment of carcinoid syndrome diarrhea in combination with 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. Telotristat ethyl targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.
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 that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have 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® (telotristat ethyl) for carcinoid syndrome diarrhea, Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism 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 the safety and efficacy and therapeutic and commercial potential of XERMELO (telotristat ethyl). In addition, this press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development 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 the risk that clinical studies of telotristat ethyl may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that the FDA and other regulatory authorities may not grant regulatory approval of telotristat ethyl for the treatment of biliary tract cancer in accordance with Lexicon’s currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of telotristat ethyl in the treatment of biliary tract cancer. As a result, telotristat ethyl may never be successfully commercialized for biliary tract cancer. Other risks include Lexicon’s ability to successfully commercialize XERMELO for carcinoid syndrome diarrhea, meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other potential drug candidates, 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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