MissionIR News - Lexicon Pharmaceuticals Begins Phase 3 Clinical Trial of Telotristat Etiprate for the Treatment of Carcinoid Syndrome

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Drug given Fast Track status and Orphan Drug designation from the FDA, in addition to Orphan designation from the European Medicines Agency

We are encouraged by the consistent clinical results obtained to date.

MissionIR would like to highlight Lexicon Pharmaceuticals, Inc., a publicly traded biopharmaceutical company, focused on the discovery and development of treatments for human disease. Its portfolio of drug programs in various stages of clinical development include LX4211, a dual inhibitor of sodium-glucose cotransporters 1 and 2, which is in Phase IIb clinical trials for the treatment of type 2 diabetes; LX1032, an inhibitor of tryptophan hydroxylase, is preparing for Phase III registrational trials to reduce peripheral serotonin production without affecting brain serotonin levels in patients with carcinoid syndrome, as well as initiated a Phase II proof-of-concept trial for patients with ulcerative colitis; and LX1033, a serotonin synthesis inhibitor that is in Phase II clinical trials for the treatment of irritable bowel syndrome.

In the company’s news last week,

Lexicon Pharmaceuticals announced that a registrational, Phase 3 clinical trial of telotristat etiprate has begun. Telotristat etiprate is a new drug candidate to be used in the treatment of carcinoid syndrome, a chronic condition caused by neuroendocrine tumors that typically originate from the gastrointestinal tract. Symptoms from carcinoid syndrome include severe diarrehea and flushing episodes with continuing consequences including malnutrition, heart disease, and death. It has also been connected with excessive serotonin production from metastatic tumor cells.

Telotristat etiprate is an oral drug candidate designed to treat carcinoid syndrome through the reduction of serotonin production in patients who have carcinoid tumors. Fast Track status and Orphan Drug designation have both been bestowed upon telotristat etiprate from the U.S. Food and Drug Administration, in addition to Orphan designation from the European Medicines Agency.

“The registrational, Phase 3 study is designed to evaluate the efficacy and safety of telotristat etiprate in patients with carcinoid syndrome that is refractory to somatostatin therapy,” said Pablo Lapuerta M.D., senior vice president and chief medical officer at Lexicon. “We are encouraged by the consistent clinical results obtained to date in two Phase 2 trials that showed telotristat etiprate significantly improved multiple dimensions of carcinoid syndrome with a favorable safety profile.”

The Phase 3 registrational trial is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of telotristat etiprate as a new treatment for carcinoid syndrome that is refractory to current therapy. Two dose levels of telotristat etiprate, 250mg and 500mg three times daily (TID), will be tested along with placebo. The study will include approximately 105 patients with refractory carcinoid syndrome on background somatostatin analog therapy, assigned equally among the 3 treatment groups using a 1:1:1 randomization plan. After the 12-week treatment period, patients will enter a 36 week open-label extension period where all patients will receive telotristat etiprate 500mg TID.

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This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.

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