Shares of Lexicon Pharmaceuticals, Inc. (LXRX) were down 6.5% in the last two days after the company reported disappointing results from a phase II study.
The study evaluated the use of candidate LX1033 in patients affected with diarrhea-predominant irritable bowel syndrome (IBS-d).
In the phase II study of IBS-d (n=373), patients were randomized for 28 days and treated with either placebo or one of three different dose levels – 1000 mg twice daily, 500 mg twice daily, and 500 mg three times daily – of LX1033 for 28 days.
The primary endpoint of this phase II study was the change from baseline in stool consistency as evaluated by the Bristol Stool Form Scale. However, LX1033 failed to achieve statistical significance in the primary endpoint.
Nevertheless, a further analysis of stool consistency yielded favorable results for the LX1033 500mg three times daily dose group as compared to placebo. In addition, LX1033 had positive effects on abdominal pain in the treated group.
Meanwhile, Lexicon Pharma also completed long-term toxicology studies which will now determine the doses for phase IIb study. The phase IIb study will span 12 weeks, a duration which is more important to identify clinically meaningful changes as compared to placebo.
The news was a setback for the company. We note that Lexicon Pharma does not have any approved product in its portfolio.
Lexicon Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Actelion (ALIOF), Aeterna Zentaris Inc. (AEZS) and Vanda Pharmaceuticals (VNDA). All three carry a Zacks Rank #1 (Strong Buy).
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