Lexicon Pharmaceuticals Inc.'s (LXRX) pivotal phase III clinical trial of its oral drug candidate Telotristat etiprate in cancer patients with Carcinoid syndrome has met the primary endpoint.
The study, dubbed TELESTAR, demonstrated that patients who added Telotristat etiprate to Somatostatin analog depot injection, the standard of care, at 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period.
Lexicon received Fast Track designation and Orphan Drug status for Telotristat etiprate from the FDA in 2008 and 2012, respectively. The company is working closely with FDA to file first new drug application or NDA.
If approved, Telotristat etiprate would be the first oral treatment successfully developed for carcinoid syndrome and the first addition to the standard of care in more than 16 years.
Carcinoid syndrome is a rare disease affecting thousands of patients with neuroendocrine tumors that originate in the gastrointestinal tract and metastasize or spread to the liver or other organs.
Telotristat etiprate was discovered using Lexicon's gene science, based on Nobel Prize-winning technology. It is the company's first discovery to complete a pivotal Phase 3 clinical trial.
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.
Lexicon plans to announce complete results from the Phase 3 TELESTAR study at an upcoming scientific conference.
Lexicon retains rights to market Telotristat etiprate in the U.S. and Japan, and is building the in-house commercial infrastructure to serve the U.S. market.
Lexicon has a license and collaboration agreement with French specialty pharmaceutical company Ipsen SA (IPSEY), that was signed last October, to commercialize Telotristat etiprate globally outside the U.S. and Japan.
Noting the positive results, Ipsen Chief Scientific Officer Claude Bertrand stated, "After the approval of Somatuline Autogel as the first and only SSA for tumor control of gastro-intestinal and pancreatic neuroendocrine tumors (NETs) in the US and Europe, and the more recent acquisition of Octreopharm's nuclear medicine platform, these results are an important milestone in our strategy to become a global leader in NETs."
In the pre-market activity on Nasdaq, Lexicon shares were gaining 12.56 percent to trade at $9.50.
In Paris, Ipsen shares were gaining 2.6 percent to trade at 60.04 euros.
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