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Arena Pharmaceuticals Announces Positive Lorcaserin Pivotal Phase 3 Obesity Trial Results: Meets All Primary Efficacy and Safety Endpoints
Date:3/30/2009

Patient Disposition

Patient demographic characteristics at baseline were well balanced across the treatment groups. The Week 52 completion rate was higher for patients on lorcaserin (55.4%) compared to those on placebo (45.1%). The difference is primarily attributed to higher discontinuation rates for "Subject Decision" (19.2% lorcaserin vs. 27.7% placebo), which includes "Lack of Efficacy" (1.7% lorcaserin vs. 5.5% placebo). Discontinuations for adverse events (7.1% lorcaserin vs. 6.7% placebo) and other reasons were similar.

Completion rates for Year 2 were similar across the treatment groups: 74.3%, 72.7%, and 68.9% for patients continuing on lorcaserin for both years, patients taking placebo both years, and patients switching from lorcaserin to placebo in Year 2, respectively. Discontinuations for adverse events were also similar across the treatment groups.

"The positive outcome of the BLOOM trial serves as a very significant milestone for Arena, demonstrating lorcaserin's potential to provide a new treatment option for patients who need to lose weight and keep it off," stated Jack Lief, Arena's President and Chief Executive Officer. "Given lorcaserin's status as the only novel, single agent weight loss therapeutic in Phase 3 development, as well as data that continues to support our expectation for a well-tolerated and efficacious drug, I expect to have a range of commercialization options to consider."

BLOOM Trial Design

BLOOM, the first of three lorcaserin Phase 3 trials, is a double-blind, randomized, placebo-controlled trial involving 3,182 patients in approximately 100 sites in the US. The trial evaluated 10 mg of lorcaserin dosed twice daily versus placebo over a two-year treatment period in obese patients (Body Mass Index, or BMI, 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to less than 30) with at least one co-morbid cond
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SOURCE Arena Pharmaceuticals, Inc.
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