Oramed shares disappointing top-line results from phase 3 trial for type 2 diabetes treatment

Clinical stage pharmaceutical company, Oramed Pharmaceuticals, has announced top-line results from its phase 3 randomised, double-blind, placebo-controlled, multicentre trial, which assessed the efficacy of ORMD-0801 compared to a placebo group. The drug is intended to treat type 2 diabetes patients by improving their glycemic control.

The trial included 710 patients with type 2 diabetes and inadequate glycemic control who were on two or three oral glucose-lowering agents. Patients were split into four groups who were dosed as follows: 8mg once-daily, 8mg twice-daily, placebo once-daily, placebo twice-daily.

However, the trial did not meet its primary endpoint to improve glycemic control enough to be significant compared to a placebo. The trial’s secondary endpoint was also not achieved, as the drug failed to change the fasting plasma glucose at 26 weeks.

There were no serious side effects or adverse events reported during the trial, however due to the disappointing results, Oramed are expected to discontinue the drug’s development.

Commenting on the disappointing outcome of the trial, Nadav Kidron, Oramedi’s chief executive officer, said, “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. We thank all the patients, families and healthcare professionals who participated in the trial.”

Betsy Goodfellow