Arena Pharmaceuticals and Eisai Inc. recently released results of a phase 3 clinical trial for lorcaserin, a weight-loss drug they are developing in partnership. The trial, called BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management- Diabetes Management), targeted patients with type 2 diabetes who are overweight or obese.
According to PR Newswire, lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI 30 or more) or patients who are overweight (BMI 27 or more) and who have at least one weight-related comorbid condition. Lorcaserin is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism.
The study found that use of lorcaserin “demonstrates statistically significant weight loss in obese and overweight patients with type 2 diabetes. In this trial, lorcaserin met all three co-primary efficacy endpoints. In addition, … lorcaserin patients taking lorcaserin 10 mg twice daily (BID) achieved statistically significant improvements in multiple secondary endpoints, including HbA1c, as compared to patients randomized to placebo.”
By the end of the 52-week study, 37.5 percent of patients treated with lorcaserin 10 mg BID achieved at least five percent weight loss, as opposed to only 16.1 percent of patients taking placebo. Patients treated with lorcaserin 10 mg BID achieved mean weight loss of 4.5 percent (4.7 kg), compared to 1.5 percent (1.6 kg) for placebo. Also, at Week 52, 16.3 percent of lorcaserin 10 mg BID patients achieved at least 10 percent weight loss, compared to 4.4 percent of patients taking placebo.
Side effects reported were headache, upper respiratory infection, back pain, and nasopharyngitis. Hypoglycemia was also reported, which included asymptomatic low blood glucose measurements by 29.3 percent and 21.0 percent of lorcaserin 10 mg BID and placebo patients, respectively; however, no events of severe hypoglycemia were reported in either treatment group.
The latest results bode somewhat well for a drug that has been afflicted by confusion in the industry and resistance from the FDA over the past year. Investment in Arena Pharmaceuticals has been up and down since 2009, with the company raising $60 million in 2010. But on September 15th, news broke that lorcaserin had been linked to malignant tumors in rats. A day later, an FDA advisory panel voted to recommend against approval of the drug, based on concerns over both safety and efficacy. This led to a 40 percent drop in Arena shares. On October 23, 2010, the FDA stated that it that it could not approve the application for lorcaserin in its present form.
Arena is pushing on though, announcing these latest results in hopes that confidence in the drug will be restored. “We look forward to reviewing the BLOOM-DM data with the FDA as the efficacy results are aligned with the agency’s categorical benchmark for weight management,” said Jack Lief, Arena’s President and Chief Executive Officer.