Lexicon Pharmaceuticals Reports On Clinical Program Status And 2012 Second Quarter Results

Lexicon Pharmaceuticals, Inc. LXRX today updated its drug development progress and reported financial results for the three and six months ended June 30, 2012. "Our positive top-line results from the Phase 2b study of LX4211 mark a very important milestone in the advancement of Lexicon's clinical pipeline towards late-stage development," said Dr. Arthur T. Sands, president and chief executive officer of Lexicon. "We believe the robust reductions in hemoglobin A1c, body weight and blood pressure are driven by LX4211's unique, dual mechanism of action and that these findings, combined with the favorable safety profile observed, support progression of LX4211 into Phase 3 development." Key Progress in Clinical Pipeline Lexicon announced positive top-line data from a Phase 2b study of LX4211, an oral, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), in patients with poorly-controlled type 2 diabetes who were concurrently treated with metformin, an established diabetes therapy. LX4211 treatment produced substantial, dose-dependent and statistically-significant reductions in hemoglobin A1c (HbA1c), with patients in the LX4211 treatment arms (75 mg QD, 200 mg QD, 200 mg BID and 400 mg QD) having mean HbA1C reductions from baseline of 0.43, 0.52, 0.79 and 0.95 percent, respectively (p<0.001 for all treatment arms). In patients randomized to placebo, HbA1C decreased by 0.09 percent. LX4211 treatment also produced significant reductions in body weight and blood pressure. Importantly, LX4211 was well tolerated and exhibited a favorable safety profile in the study. Lexicon also announced that it received funding for, and is preparing to initiate, a Phase 2 clinical trial of LX4211 in patients with type 1 diabetes. Lexicon completed an open-label Phase 2 clinical trial of telotristat etiprate (LX1032), an inhibitor of tryptophan hydroxylase that reduces peripheral serotonin production without affecting brain serotonin levels, in patients with carcinoid syndrome and anticipates announcing results in the third quarter of 2012. Lexicon is proceeding with preparations for Phase 3 registrational trials of telotristat etiprate in patients with carcinoid syndrome and continues to enroll patients in a Phase 2 proof-of-concept trial evaluating the effect of telotristat etiprate on symptoms associated with ulcerative colitis. Lexicon continues to enroll patients with diarrhea-predominant irritable bowel syndrome (IBS-d) in a Phase 2 trial of LX1033, an inhibitor of tryptophan hydroxylase that acts locally in the gastrointestinal tract. Lexicon completed a dose-ranging study exploring higher doses of LX2931, an inhibitor of sphingosine-1-phosphate lyase, in patients with rheumatoid arthritis and anticipates announcing results in the third quarter of 2012. Lexicon completed a Phase 1-2 proof-of-concept study of LX7101 in glaucoma patients and anticipates announcing results in the third quarter of 2012. LX7101 targets LIM domain kinase 2 (LIMK2), a novel mechanism of action that Lexicon research identified in preclinical models as reducing intraocular pressure by allowing more fluid to flow through the trabecular meshwork of the anterior chamber of the eye. Revenues: Lexicon's revenues for the three months ended June 30, 2012 decreased 64 percent to $0.2 million from $0.6 million for the corresponding period in 2011. The decrease for the three months ended June 30, 2012 was primarily attributable to reduced revenues from the United States Army Medical Research Acquisition Activity and functional genomics contracts. For the six months ended June 30, 2012, revenues decreased 57 percent to $0.5 million from $1.2 million for the corresponding period in 2011.