Oramed’s insulin pill fails PhIII trial in diabetes, stock craters
Oramed Pharmaceuticals’ quest to develop an insulin pill for Type II diabetes just got stonewalled.
The biotech said its Phase III trial testing the oral insulin capsule ORMD-0801 failed to improve glycemic control compared to placebo. The trial didn’t meet its primary endpoint, which measured the mean change in A1C, a blood sugar level test, from baseline after half a year.
The biotech’s stock $ORMP fell by over 70%, from $10.79 at Wednesday’s closing to less than $3 a share Thursday morning.
The Phase III trial also did not meet a secondary endpoint looking at a different blood sugar test — fasting plasma glucose — which measured the amount of glucose in the blood of participants who haven’t eaten for at least eight hours.
As a result, Oramed plans to discontinue development of its insulin pill for Type II diabetes, it said in a press release. Oramed CEO Nadav Kidron said in a statement, “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.”
The biotech had been developing the pill as an easier way of delivering insulin, as opposed to through a needle or pump. Oramed says its capsule can protect the insulin from the harsh pH and enzymes of the gut, and can help it get absorbed through the intestinal wall. Another biotech, i2o Therapeutics, which is partnered with J&J and Sanofi, is likewise working on an oral delivery method that can protect treatments from the caustic gut environment. And one of the indications it’s working towards is also Type II diabetes.
Oramed is also testing its oral insulin treatment for NASH and has an oral GLP-1 analog in early-stage studies, according to its website. Oramed completed a Phase II for its oral insulin in NASH in November, but the study was not powered to look at statistically significant differences between treatment groups.