Arena Pharma (ARNA) Reports Pivotal BLOOM Phase III data

October 26, 2009 7:30 AM EDT

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) reported that data from the pivotal BLOOM (Behavioral 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.

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% of their excess weight compared to 12.0% 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% of lorcaserin patients and 16.1% 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% and 3.0%. 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.

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%) of lorcaserin patients lost at least 5% of their weight, compared to 32.1% of patients on placebo, and over one-third (36.2%) of lorcaserin patients lost at least 10% of their weight, compared to 13.6% 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% of Year 1 lorcaserin responders maintained at least 5% weight loss during Year 2, compared to 50.3% 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% of their body weight by Week 8.

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