Oramed Pharma Shares Sink After Diabetes Candidate Fails In Phase 3 Study

  • Oramed Pharmaceuticals Inc ORMP announced top-line results from its Phase 3 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.
  • CEO Nadav Kidron commented, "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."
  • In November, Oramed announced additional data from its Phase 2 trial (ORA-D-N02) of oral insulin candidate (ORMD-0801) to reduce liver fat content in Type 2 Diabetes patients with non-alcoholic steatohepatitis (NASH). 
  • The whole Liver showed a placebo-adjusted mean decrease in liver fat content of 0.96 with a placebo-adjusted median decrease of 6.0 for ORMD-0801.
  • Price Action: ORMP shares are down 68% at $3.45 during the premarket session on the last check Thursday.
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