THE WOODLANDS, Texas, Jan. 24, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today real-world data on XERMELO’s® (telotristat ethyl) antiproliferative effects in patients with carcinoid syndrome that were presented at the American Society for Clinical Oncology (ASCO) 2020 Symposium (January 23-25, San Francisco, CA). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.
Data from a retrospective, pre- and post-design chart review of 200 metastatic neuroendocrine tumor patients who were on standard background therapies and received telotristat ethyl for an average of 12 months in US clinical practice demonstrated significant mean tumor size reduction of 0.59 cm after initiation of telotristat ethyl (p = 0.006).“We are pleased this observational study showed that use of telotristat ethyl was associated with neuroendocrine tumor control,” said Pablo Lapuerta, executive vice president and chief medical officer of Lexicon. “These findings are consistent with preclinical data suggesting that serotonin may promote tumor growth. Such preclinical data and the results of this observational study support the conduct of clinical trials to examine telotristat ethyl’s effect on neuroendocrine tumors.”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 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 InformationWarnings 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 PharmaceuticalsLexicon is a fully integrated biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000
Head of Investor Relations and Corporate Strategy
Lexicon Pharmaceuticals
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klee@lexpharma.comFor Media Inquiries:Chas Schultz
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Lexicon Pharmaceuticals
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