BioWorld International Correspondent

PARIS - NicOx SA is to conduct two more Phase II trials of NCX 4016 to test it as a novel insulin sensitizing agent for the treatment of Type II diabetes.

The trials are due to get under way within the next six months and will be designed to confirm the drug's mechanism of action as an insulin sensitizer and demonstrate clinical benefit in the treatment of Type II diabetes.

NicOx, of Sophia Antipolis, France, said its decision to continue the development of NCX 4016 in that indication follows the results obtained from three previous trials in a cardiometabolic setting. At the same time, it announced that it "has no current plans to develop NCX 4016 further in peripheral arterial obstructive diseases (PAOD)."

"In light of the Type II diabetes pandemic that is appearing in the developed world, there is a clear need for a new class of oral treatments, which could counteract insulin resistance through an alternative mechanism," said NicOx's vice president of clinical development, Maarten Beekman. "There is a solid scientific rationale supporting the development of NCX 4016 as an insulin sensitizing agent based on the known effects of nitric oxide and salicylate, and the recent finding that NCX 4016 releases higher and more sustained levels of salicylate than previously thought. Clinical results also suggest these mechanisms may benefit the vascular complications of Type II diabetes."

The first of the Phase II trials will be a single-center, crossover trial to confirm increased insulin sensitivity through the use of a hyperinsulinemic euglycemic clamp, the same technique used in an earlier Phase IIa trial. The second will be a double-blind, parallel trial using a placebo as a control to demonstrate the clinical benefit of NCX 4016 through the measurement of HbA1c (glycosylated hemoglobin) and blood glucose levels.

Meanwhile, NicOx reported its financial results for the first half of this year, showing that its revenues tripled to €3.7 million (US$4.74 million) (from €1.2 million in the corresponding period of 2005), while its operating expenses more than doubled to €19 million (from €8.6 million), due to the start of Phase III trials of naproxcinod (its leading COX-inhibiting nitric oxide-donating compound) for osteoarthritis in the U.S. Following a private placement that netted it €43 million and an up-front payment of €9.2 million from Merck & Co. Inc., of Whitehouse Station, N.J., from their deal signed in March, NicOx had cash and cash equivalents of €97.6 million as at June 30 last, compared with €42.6 million at the end of 2005.