New York-based Oramed Pharmaceuticals have recently announced that its experimental type 2 anti-diabetic oral drug ORMD-0801 has failed to meet the trial endpoints during a Phase 3 randomised double-blind, placebo-controlled, multicentre clinical trial (ORA-D-013-1) comparing the efficacy of ORMD-0801 to placebo in patients with Type 2 Diabetes (T2D) at 26 weeks.
Terming the results disappointing, the company said in a recent statement that the drug could not meet both the primary and secondary endpoints of the trial.
The ORA-D-013-1 trial did not meet its primary endpoint, which compared the efficacy of ORMD-0801 to placebo in improving glycaemic control as assessed by the mean change from baseline in A1C at 26 weeks, the statement read.
Hinting that Oramed may discontinue its oral insulin clinical activities for type 2 diabetes, the company said that the trial also did not meet its secondary endpoint, which assessed the mean change from baseline in fasting plasma glucose at 26 weeks.
“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,” Oramed’s Chief Executive Officer, Nadav Kidron, stated.
During the trial, patients were randomised 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.
The statement added that patients completed an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period.