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Oramed Pharmaceutical’ (NASDAQ:ORMP) the drug ORMD-0801 failed to meet the primary endpoint of improving blood sugar levels, compared with placebo, in patients with type 2 diabetes (T2D) in a phase 3 trial.
Oramed indicated that he expects discontinue their oral insulin clinical activities for T2D.
The study, called ORA-D-013-1, enrolled 710 T2D patients with inadequate glycemic control on two or three oral hypoglycemic agents.
Patients were randomized 2:2:1:1 into four groups: 8 mg dosed once daily; 8 mg administered twice daily; placebo dosed once daily; and placebo dosed twice daily.
The company said the study did not meet its primary objective, 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 endpoint, which assessed the mean change from baseline in fasting plasma glucose at 26 weeks, the company added.
There were no serious adverse events related to the drug, according to Oramed.
“Today’s result is very disappointing, given the positive results from previous trials. Once full data from the studies are available, we look forward to sharing relevant learnings and future plans,” said Oramed CEO Nadav Kidron.
ORMP -69.97% to $3.24 before marketing on January 12
