Oramed Pharmaceuticals (Nasdaq:ORMP) announced that top-line Phase 3 trial results for its oral insulin candidate missed its endpoints.
The Phase 3, randomized, double-blind, placebo-controlled trial compared the efficacy of ORMD-0801 to placebo. It evaluated patients with type 2 diabetes at 26 weeks. ORA-D-013-1 enrolled 710 patients with T2D and inadequate glycemic control. Those patients were also on two or three oral glucose-lowering agents.
Oramed’s trial failed to meet its primary endpoint comparing efficacy in improving glycemic control. It assessed efficacy by the mean change from baseline in A1C at 26 weeks.
The trial also failed to meet its secondary endpoint of the mean change from baseline in fasting plasma glucose at 26 weeks. It recorded no serious drug-related adverse events. Oramed said it expects to discontinue its oral insulin clinical activities for T2D.
“Today’s outcome is very disappointing, given the positive results from prior trials,” said Oramed CEO Nadav Kidron. “Once full data from the studies are available, we expect to share relevant learnings and future plans. We thank all the patients, families and healthcare professionals who participated in the trial.”
Oramed aims to change the treatment of diabetes with its ORMD-0801 oral insulin capsule. The capsule is currently under evaluation in a second pivotal Phase 3 trial. The company recently inked a deal to commercialize the oral insulin treatment in the Republic of Korea. It also picked up a new patent for its oral diabetes treatment earlier this month.