Oramed’s oral insulin candidate fails to meet phase 3 targets

Oramed Pharmaceuticals (Oramed) has said that it expects to discontinue its oral insulin clinical activities for type 2 diabetes after a phase 3 trial of its oral insulin candidate, ORMD-0801, produced ‘disappointing’ results.

The phase 3 ORA-D-013-1 trial compared the company’s proprietary lead candidate to placebo and enrolled 710 patients with type 2 diabetes and inadequate glycemic control on two or three oral glucose-lowering agents.

The 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 failed to reach 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, the company said.

Oramed’s chief executive officer, Nadav Kidron, said: “Today’s outcome is very disappointing, given the positive results from prior trials. Once full data from the studies is available, we expect to share relevant learnings and future plans.

“We thank all the patients, families and healthcare professionals who participated in the trial.”

The announcement comes just months after the company reported positive results from its phase 2 trial assessing the safety and efficacy of ORMD-0801 to reduce liver fat content in type 2 diabetes patients with non-alcoholic steatohepatitis (NASH).

The additional results, announced by the company in November, demonstrated that ORMD-0801 was safe and well tolerated, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo.

Kidron said at the time that the company was “very encouraged” by the data, adding that consistent trends across key secondary endpoints had been observed.

“This indicates that our oral insulin may be an ideal treatment option for the millions of diabetes and NASH patients, as the global market for drugs to treat NASH is expected to reach $84bn by 2029. Using oral insulin to treat NASH opens a world of possibilities,” Kidron said.

In addition to ORMD-0801, Oramed currently has an oral Glucagon-like Peptide 1 analog capsule, ORMD-0901, in clinical development.

The company’s subsidiary, Oravax Medical, is also developing an oral COVID-19 vaccine candidate, for which it announced positive preliminary phase 1 data in October last year.