Arena Pharmaceuticals, Inc reported that data from the pivotal BLOOM (Behavioural modification and Lorcaserin for Overweight and Obesity Management) phase-3 trial demonstrate lorcaserin significantly increased excess weight loss, improved markers of cardiovascular risk and glycemic parameters, and was not associated with depression or suicidal ideation. Additional subgroup analyses showed that lorcaserin caused the greatest improvements in lipid profiles, glycemic parameters and other markers of cardiovascular risk in patients in the highest risk categories. The new data were presented at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society.

"There is an enormous unmet need for new weight management treatments to help address the obesity epidemic. If approved, lorcaserin's unique combination of efficacy, safety and tolerability will make it suitable as first-line therapy for weight management," said Steven R Smith, executive director of the Florida Hospital Translational Research Institute for Metabolism and Diabetes. "Based on the results from lorcaserin's pivotal program, physicians and patients can expect treatment with lorcaserin, along with a lifestyle modification program, to result in average weight loss of nearly 20 pounds and a significant reduction in their excess weight over one year, while improving important risk factors and quality of life. Lorcaserin was very well tolerated; the most common side effect was mild and transient headache early in treatment."

Specifically, the new data show that lorcaserin increased excess weight loss during Year 1 of the BLOOM trial. Lorcaserin patients who completed the trial according to protocol lost 31.0 per cent of their excess weight compared to 12.0 per cent for the placebo group. This measurement is based on a normal Body Mass Index, or BMI, of 25. In addition to the previously announced improvements in glycemic parameters, including fasting glucose, fasting insulin and HOMA-IR, lorcaserin patients also achieved highly significant improvements in HbA1C over one year of treatment (p<0.0001). The greatest improvements were observed in patients with abnormal baseline values.

Quality of Life, as assessed by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, also improved to a significantly greater extent in the lorcaserin group than the placebo group at Week 52 (p<0.005). Lorcaserin patients achieved improvements over placebo in all subscores of the IWQOL-Lite, including physical function, self esteem, sexual life, public distress and work.

In addition to the previously announced tolerability data, today's presentation also reported that lorcaserin demonstrated no increase in depression or suicidal ideation compared to placebo. Depression and suicidal ideation were monitored prospectively using the Beck Depression Inventory-II (BDI-II) and by adverse event reporting. At Week 52, 18.0 per cent of lorcaserin patients and 16.1 per cent of placebo patients reported at least a five-point improvement from baseline in BDI-II. A smaller number of lorcaserin patients had increases in the BDI-II total score as compared to placebo. Adverse events related to depression and their total rates at Year 1 for patients who took lorcaserin or placebo, respectively, were 3.1 per cent and 3.0 per cent. In addition, cumulative incidence of suicidal ideation was prospectively evaluated by administration of the BDI-II Questionnaire and did not differ between the lorcaserin and placebo groups at each measurement through two years of treatment.

Christen M Anderson, Arena's vice president of Clinical Development stated, "Drug candidates that act on the central nervous system are currently under tremendous scrutiny for any association with depression or suicidal ideation. Lorcaserin's selective activation of an important receptor associated with reduced food intake avoids these liabilities. We believe the data presented at Obesity 2009 will support our new drug application and we look forward to working with the FDA to provide physicians and patients with lorcaserin."

Previously announced BLOOM data demonstrate that lorcaserin helped patients achieve clinically meaningful weight loss and maintenance of weight loss over two years of treatment. In the per protocol population, nearly two-thirds (66.4 per cent) of lorcaserin patients lost at least 5 per cent of their weight, compared to 32.1 per cent of patients on placebo, and over one-third (36.2 per cent) of lorcaserin patients lost at least 10 per cent of their weight, compared to 13.6 per cent for placebo. The average weight loss in this population was 17.9 pounds in the lorcaserin group, compared to 7.4 pounds in the placebo group. Using ITT-LOCF analysis, 67.9 per cent of Year 1 lorcaserin responders maintained at least 5 per cent weight loss during Year 2, compared to 50.3 per cent for those patients re-randomized from lorcaserin treatment in Year 1 to placebo in Year 2.

Lorcaserin improved patients' lipid profiles, insulin resistance and markers of inflammation, with the greatest improvements observed in those with abnormal values at the start of the study. Treatment with lorcaserin was well tolerated, resulting in very few adverse events with greater frequency than the placebo group, and did not increase cardiac valvulopathy. Lorcaserin's tolerability profile eliminates the need for titration; patients began treatment on the full dose and achieved rapid weight loss. Almost one-third of lorcaserin patients lost at least 5 per cent of their body weight by Week 8.

Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists.

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.