Oramed Pharmaceuticals Inc, a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced top-line results from its phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial (ORA-D-013-1) comparing the efficacy of ORMD-0801 to placebo in patients with Type 2 Diabetes (T2D) at 26 weeks. ORA-D-013-1 enrolled 710 patients with T2D and inadequate glycemic control on two or three oral glucose-lowering agents.
The ORA-D-013-1 trial did not meet its primary endpoint, which compared the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by the mean change from baseline in A1C at 26 weeks. The trial also did not meet its secondary endpoint, which assessed the mean change from baseline in fasting plasma glucose at 26 weeks. There were no serious drug-related adverse events. Therefore, Oramed expects to discontinue its oral insulin clinical activities for T2D.
"Today's outcome is very disappointing, given the positive results from prior trials. 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," said Nadav Kidron, Oramed's CEO.
In the ORA-D-013-1 clinical trial, patients were randomized 2:2:1:1 into four groups: 8 mg dosed once-daily; 8 mg dosed twice-daily; placebo dosed once-daily; and placebo dosed twice-daily. Patients completed an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period. More information on the trial can be found here: ORA-D-013-1
