THE WOODLANDS, Texas, - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three months and six months ended June 30, 2009.
"Our clinical development programs continue to progress, including the recent initiation of a Phase 2 study of LX1032 in patients with carcinoid syndrome," said Dr. Arthur T. Sands, president and chief executive officer of Lexicon. "We also expect to advance LX2931 for rheumatoid arthritis into a Phase 2 clinical trial in the very near future."
Key Developments
Lexicon advanced its LX1032 drug candidate, which has received Fast Track status from the U.S. Food and Drug Administration (FDA), into a Phase 2a study in patients with carcinoid syndrome. The Phase 2 clinical trial is designed as a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX1032 and its effects on symptoms associated with carcinoid syndrome. The study will include up to 28 patients with carcinoid syndrome who are symptomatic despite treatment with currently available therapy. In addition, Lexicon presented Phase 1 data for LX1032 at the Digestive Disease Week (DDW) annual meeting on June 1, 2009. Most recently, Lexicon received orphan drug designation for LX1032 from the European Medicines Agency.
Lexicon completed the multiple ascending-dose portion of a Phase 1 study of its LX4211 drug candidate to evaluate the safety, tolerability, and pharmacokinetics of LX4211 in healthy volunteers over a seven-day dosing period. Top-line results from the Phase 1 clinical trial will be available later this quarter.
Lexicon is preparing to initiate a Phase 2a study of LX2931 in patients with rheumatoid arthritis. Lexicon has identified the clinical trial sites for the Phase 2 study, and patient enrollment is expected to begin in the third quarter of 2009. In addition, Lexicon presented Phase 1 data for LX2931 at the European League Against Rheumatism (EULAR) annual meeting on June 13, 2009.
Lexicon continues to enroll patients in a Phase 2a clinical trial of its LX1031 drug candidate for non-constipating irritable bowel syndrome (IBS). Enrollment is on track to be completed by year-end. The trial is designed as a double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of LX1031 and its effects on symptoms associated with IBS. In addition, Lexicon presented Phase 1 data for LX1031 at the Digestive Disease Week (DDW) annual meeting on May 31, 2009.
Ajay Bansal, formerly of Tercica, Inc., was appointed executive vice president of corporate development and chief financial officer, responsible for leading the company's pharmaceutical partnering and licensing efforts. Mr. Bansal has more than 20 years of experience in the biotechnology and pharmaceutical industry in corporate finance, corporate and business development, strategic planning, and commercial operations.
