Arena Pharmaceuticals, Inc announced preliminary data from a phase-2b clinical trial of APD125 measuring subjective endpoints in patients with primary insomnia. The initial data analysis indicates that APD125 did not meet the trial's primary or secondary endpoints. Treatment with APD125 was well tolerated, and there were no reports of serious adverse events and no emerging safety findings as compared to placebo. Arena is finishing a complete analysis of the data, but does not anticipate any further development of APD125.
"While we are disappointed and anticipated a different result based on objective polysomnographic results from our previous studies, our priority remains the successful development of lorcaserin, our proprietary investigative treatment for obesity. We expect to announce lorcaserin results from BLOOM, our first pivotal phase-3 clinical trial, around the end of March and to file a New Drug Application for lorcaserin by the end of 2009," said Jack Lief, Arena's president and chief executive officer. "We look forward to the opportunity to review our lorcaserin program, as well as other programmes, at our upcoming R&D Day on December 15."
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.