(By Balaseshan) Lexicon Pharmaceuticals Inc. (NASDAQ: LXRX) shares soared 9.63% in premarket after the biopharmaceutical company received "Fast Track" status for irritable bowel syndrome drug candidate.
The company has received "Fast Track" status from the U.S. Food and Drug Administration (FDA) for the development of LX1033, an orally-delivered small molecule drug candidate for diarrhea-predominant irritable bowel syndrome (IBS-d).
LX1033, an inhibitor of tryptophan hydroxylase (TPH) that acts locally in the gastrointestinal tract, is currently being evaluated in a Phase 2 clinical trial for IBS-d.
The Phase 2 trial is a randomized, double-blind study designed to evaluate the safety and efficacy of LX1033 versus placebo in about 360 IBS-d patients, with results expected in the first half of 2013.
LX1033 is a follow-on compound to LX1031, a previous-generation oral, locally-acting TPH inhibitor developed by Lexicon which had previously shown clinical benefit in a Phase 2 trial for IBS-d. Results from the LX1031 Phase 2 trial have been published in the journal Gastroenterology.
Fast Track is a process designed to facilitate the development and expedite the review of new drugs intended to serve unmet medical needs in serious or life-threatening conditions. Fast Track status provides formal mechanisms for sponsors to communicate with the FDA on product development issues, including clinical trial design.
Marketing applications for Fast Track development programs are likely to be considered appropriate for priority review, which may shorten the time to FDA approval. Lexicon also has FDA Fast Track status for telotristat etiprate, or LX1032, an oral, systemic TPH inhibitor currently in Phase 3 development for carcinoid syndrome.
Lexicon Pharmaceuticals uses its gene knockout technologies and an integrated platform of medical technologies to study the physiological and behavioral functions of almost 5,000 genes in mice and assessed the utility of the proteins encoded by the corresponding human genes as drug targets.
LXRX closed Friday's regular session up 5.65% at $1.87. The stock has been trading between $0.94 and $3.28 for the past 52 weeks.