Oramed soars on successful oral insulin trial

Shares of Israeli diabetes specialist Oramed Pharmaceuticals (Nasdaq: ORPM) shot up 23.8% to $3.02 in pre-market US trading today, after it announced positive results from the initial cohort of the Phase IIb trial evaluating the efficacy and safety of its lead oral insulin candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of diabetes.

The much anticipated placebo-controlled, double-blinded, randomized, 90-day dose-ranging Phase IIb trial in type 2 diabetes (T2D) patients with inadequate glycemic control on oral antihyperglycemic agents, assessed the change in A1C, the primary efficacy endpoint, from baseline to week 12, as well as safety endpoints, when ORMD-0801 was given in different regimens across a dose range.

Patients randomized in the trial to once-daily ORMD-0801 achieved a reduction in mean A1C of 0.60% from baseline, or a reduction of 0.54% adjusted for placebo (p value = 0.036). This 0.54% reduction in A1C is considered clinically meaningful, reflecting an improved glucose control that would result in reduced risk of developing diabetes-related complications.