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LEXICON’S DRUG CANDIDATE FOR IRRITABLE BOWEL SYNDROME RECEIVES FAST TRACK STATUS FROM THE FDA
The Woodlands, Texas, December 17, 2012 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has received “Fast Track” status from the U.S. Food and Drug Administration (FDA) for the development of LX1033, an orally-delivered small molecule drug candidate for diarrhea-predominant irritable bowel syndrome (IBS-d).
“We are pleased with the FDA’s grant of Fast Track status for LX1033 in IBS-d, recognizing this important area of unmet medical need and the potential benefits that LX1033 could provide for those suffering from this disease,” said Pablo Lapuerta, M.D., senior vice president and chief medical officer at Lexicon.
LX1033, an inhibitor of tryptophan hydroxylase (TPH) that acts locally in the gastrointestinal tract, is currently being evaluated in a Phase 2 clinical trial for IBS-d. The Phase 2 trial is a randomized, double-blind study designed to evaluate the safety and efficacy of LX1033 versus placebo in approximately 360 IBS-d patients, with results expected in the first half of 2013. LX1033 is a follow-on compound to LX1031, a previous-generation oral, locally-acting TPH inhibitor developed by Lexicon which had previously shown clinical benefit in a Phase 2 trial for IBS-d. Results from the LX1031 Phase 2 trial have been published in the journal Gastroenterology (2011; 141:507-516).
About Fast Track
Fast Track is a process designed to facilitate the development and expedite the review of new drugs intended to serve unmet medical needs in serious or life-threatening conditions. Fast Track status provides formal mechanisms for sponsors to communicate with the FDA on product development issues, including clinical trial design. Marketing applications for Fast Track development programs are likely to be considered appropriate for priority review, which may shorten the time to FDA approval. Lexicon also has FDA Fast Track status for telotristat etiprate, or LX1032, an oral, systemic TPH inhibitor currently in Phase 3 development for carcinoid syndrome.
Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease. Lexicon currently has four drug programs in mid-stage development for diabetes, irritable bowel syndrome, carcinoid syndrome and rheumatoid arthritis, all of which were discovered by Lexicon’s research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs. For additional information about Lexicon and its programs, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of LX1033, including characterizations of the results of and projected timing of clinical trials, and the potential therapeutic and commercial potential of LX1033. 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 those relating to Lexicon’s ability to successfully conduct clinical development of LX1033 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, 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, that 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, 2011, 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.