juststock/iStock via Getty Images
juststock/iStock via Getty Images
Oramed Pharmaceuticals’ (NASDAQ:ORMP) drug ORMD-0801 did not meet the main goal of improving blood sugar levels, compared to placebo, in patients with Type 2 Diabetes (T2D) in a phase 3 trial.
Oramed noted that it expects to discontinue its oral insulin clinical activities for T2D.
The study, dubbed ORA-D-013-1, enrolled 710 patients with T2D and inadequate glycemic control on two or three oral glucose-lowering agents.
The 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.
The company said the study did not meet its main goal, which compared the efficacy of ORMD-0801 to placebo in improving glycemic control as tested by the average change from baseline in A1C (also known as hemoglobin A1C) at 26 weeks.
The trial also did not meet its secondary goal, which assessed the mean change from baseline in fasting plasma glucose at 26 weeks, the company added.
There were no serious drug-related adverse events, according to Oramed.
“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,” said Oramed’s CEO Nadav Kidron.
ORMP -69.97% to $3.24 premarket Jan. 12