Oramed’s oral insulin flunks phase 3 diabetes test, sending stock down 70%

Oramed Pharmaceuticals’ dream of developing an oral insulin for type 2 diabetes looks to be over. With the candidate failing to beat placebo in a phase 3 trial, the biotech outlined plans to stop development and sent its share price tumbling in the process. 

For years, Oramed has plugged away at the idea that its protein oral delivery technology can transform the treatment of type 2 diabetes. By protecting insulin from the pH and proteases encountered after oral delivery, the biotech aimed to make it easier for patients with diabetes to take their medication—and improve blood glucose control and prevent weight gain into the bargain.

The phase 3 randomized, double-blind, placebo-controlled ORA-D-013-1 clinical trial was the biggest test of that idea yet. Oramed’s oral insulin ORMD-0801 comprehensively failed the test. The candidate was no better than placebo at improving glycemic control in the 26-week clinical trial, causing the study to miss its primary endpoint. 

Patients on ORMD-0801 did no better than their peers on placebo in terms of the mean change from baseline in fasting plasma glucose at 26 weeks, either, causing the trial to chalk up a secondary endpoint failure too. Oramed CEO Nadav Kidron read the last rites.

“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,” Kidron said in a statement. 

The future plans are unlikely to include the development of oral insulin in type 2 diabetes, with Oramed saying it expects to stop work on the indication. Beyond its lead project, Oramed has run clinical trials of ORMD-0801 in nonalcoholic steatohepatitis and studied its oral GLP-1 candidate ORMD-0901 in patients with type 2 diabetes. 

Investors are assigning little value to the rest of the pipeline. After dropping news of the phase 3 failure, Oramed saw its share price fall around 70% in premarket trading, sinking the stock to just above the $3 mark.