Lexicon Pharma Surges as Telotristat Meets Goals in Phase III Study

August 3, 2015
By Alex Keown, BioSpace.com Breaking News Staff

THE WOODLANDS, Texas – Lexicon Pharmaceuticals, Inc. ’s stock jumped more than 50 percent this morning after the company’s experimental cancer treatment telotristat etiprate for carcinoid syndrome met its Phase III clinical trial endpoints.

The stock hit a morning high of $13.19 per share, up more than four points from its Friday close of $8.44 per share. Lexicon, which has a market cap of $877 million, traded 947,914 shares today in the pre-market hours, representing 139.3 percent of its average daily volume, The Street reported.

The Phase III trial showed patients who used the oral telotristat etipratep as part of their standard of care in treating carcinoid syndrome reduced the average number of daily bowel movements over the 12-week study in comparison to those who took placebos. Carcinod syndrome is characterized in part by debilitating diarrhea. Additional characteristics include facial flushing, abdominal pain, heart valve damage and other serious consequences. It is estimated that about 12,000 people are diagnosed with carcinoid syndrome annually in the United States, about 8,000 in the GI tract and 4,000 in the lungs.

This morning Lexicon Chief Executive Officer Lonnel Coats said the company is committed to working closely with the U.S. Food and Drug Administration (FDA) to file a new drug application for telotristat etiprate. Lexicon received Fast Track designation and Orphan Drug status for telotristat etiprate from the FDA in 2008 and 2012, respectively.

“Carcinoid syndrome is severely debilitating, preventing many patients from leading active and predictable lives, and unfortunately, a majority of patients will not be adequately controlled over time with the current standard of care,” Coats said in a statement.

Carcinoid syndrome affects thousands of people with neuroendocrine tumors that originate in the gastrointestinal tract and metastasize or spread to the liver or other organs. The current standard of care for carcinoid syndrome is somatostatin analog depot injection, first approved in 1998. Telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase (TPH), an enzyme that triggers the excess serotonin production within mNET cells that leads to carcinoid syndrome.

The double-blind Phase III study studied 135 patients over a 12-week period. The study evaluated two doses of oral telotristat etiprate – 250 mg and 500 mg, each taken three times daily against placebo and measured the reduction from baseline in the average number of daily bowel movements. Patients in both the treatment and placebo arms continued their SSA therapy throughout the study, Lexicon said. The 12-week study period is being followed by a 36-week open-label extension where all patients receive telotristat etiprate 500 mg three times daily.

While Lexicon’s stock is soaring this morning, analysts are split on the stock, the Street reported. Currently there are three analysts that rate Lexicon Pharmaceuticals a buy, one analyst rates it a sell, and two rate it a hold, the site reported this morning.

In addition to telotristat etiprate, Lexicon is also in the process of initiating a Phase III trial for sotagliflozin type 1 diabetes. Sotagliflozin is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2).