Lexicon Pharmaceuticals, Inc. LXRX announced positive top-line data from a phase III study, TELECAST, on its pipeline candidate, telotristat etiprate.
Lexicon is evaluating telotristat etiprate for the treatment of carcinoid syndrome in patients with metastatic neuroendocrine tumors.
The three-arm TELECAST study evaluated two doses of telotristat etiprate, 250 mg and 500 mg, each taken three times daily, compared with placebo over a 12-week period.
The candidate met the study’s primary efficacy endpoint of percent change from baseline in urinary 5-hydroxyindoleacetic acid at week 12, which was the final week of the double-blind treatment portion of the study.
Results were consistent with data from the TELESTAR study. We note that Lexicon had decided to conduct the TELECAST study as a complementary study to TELESTAR, to further evaluate telotristat etiprate's activity in carcinoid syndrome and to provide additional safety exposure. The study enrolled carcinoid syndrome patients who were treated with somatostatin analog (SSA) therapy and had less frequent bowel movement than those enrolled in TELESTAR.
We note that telotristat etiprate enjoys orphan drug status and fast track designation in the U.S. Successful development and commercialization of the candidate will be a significant boost for Lexicon as it does not have any approved product in its kitty yet.
Lexicon has a commercialization agreement with Ipsen Pharma SAS for telotristat etiprate. Under this agreement, while Lexicon has rights to market telotristat etiprate (upon approval) in the U.S. and Japan, Ipsen will commercialize it in Europe and other countries outside the U.S. as well as Japan.
Lexicon carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Eli Lilly and Company LLY, AstraZeneca PLC AZN and Biodel Inc. BIOD. AstraZeneca sports a Zacks Rank #1 (Strong Buy), while Eli Lilly and Biodel carry a Zacks Rank #2 (Buy).
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