Contenders in a race to develop drugs in a new class of blood-sugar lowering meds presented data from key studies today, showing the promise of the SGLT2 inhibitors along with some of the safety issues associated with such treatments. Johnson & Johnson ($JNJ) offered data from two late-stage studies of canagliflozin, which is under FDA review, while partners Eli Lilly ($LLY) and Boehringer Ingelheim showed off more evidence of the efficacy on their SGLT2 drug empagliflozin from an analysis of data from a pair of mid-stage studies. Both groups touted the data at the European Association for the Study of Diabetes annual meeting in Berlin.
The two drugs are among a dozen or so such treatments at various stages of development, as major pharma companies seek new ways to help the swelling population of diabetics control glucose levels and avoid complications, Bloomberg reported. The SGLT2 inhibitors act on a different mechanism than insulin, stymieing glucose in the kidneys and allowing it to exit the body via urine. In January the FDA blocked from the market such a drug from AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) over safety concerns, and the next contenders in the pipeline face a similar safety hurdle to gain approval.
Johnson & Johnson, which aims to gain a foothold in the big diabetes market with canagliflozin, presented data from part of its major "CANVAS" study of 4,330 patients with Type II diabetes at risk of heart disease, the top cause of death in the patient population. In the 18-week sub-study of 1,718 patients in the trial who had taken insulin for an average of 7.1 years, patients on J&J's drug had greater A1C reductions and weight loss than those on placebo, according to the company. And data from a second Phase III study showed the drug helped older diabetics also taking antihyperglycemic therapy lower A1C levels better than in the placebo group.
Yet more patients on a 300 mg dose of J&J's SGLT2 drug had to drop out of the CANVAS study compared with those on placebo because of adverse events. Patients on the drug showed higher increases in cholesterol levels and hypoglycemia, while other conditions such as urinary tract infections and increased urination were also more common among patients on J&J's drug. The company said that those safety data are included in submissions in the U.S. and Europe for market approval of the treatment.
Lilly and Boehringer, which aim to file for FDA approval of empagliflozin in 2013, shed light on one of the benefits of the drug in Type II diabetics. The analysis came from two Phase IIb studies and showed a lowering of blood pressure in patients on the drug. The partners are now conducting a dozen late-stage trials of the drug in more than 14,500 patients, with pivotal studies expected to wrap up later this year.