Oramed hits oral insulin clinical trial milestone

By Jane Byrne

- Last updated on GMT

© GettyImages/richcano
© GettyImages/richcano

Related tags Diabetes Oramed Clinical trial Oral insulin

Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the world’s first Phase 3 study of oral insulin under FDA approved protocols.

The company said the completion of the recruitment for the clinical trial of oral insulin capsule, ORMD-0801, is a big milestone, not just for Oramed, but for the development of oral insulin for the treatment of type 2 diabetes (T2D).

The ORA-D-013-1 study initially aimed at the enrollment 675 patients but has now surpassed that, having recruited a total of 710 patients. 

Established in 2006, with offices in the US and Israel, Oramed is seeking to transform the treatment of diabetes through that proprietary lead candidate. ORMD-0801, it said, has the potential to be the first commercial oral insulin capsule for the treatment of diabetes.

The patients enrolled for the late-stage study are currently on two or three oral glucose-lowering agents through 96 clinical sites throughout the US, said Oramed.

Topline results due early next year

The primary endpoint of the study is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control, with a secondary endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks.

Efficacy data will become available after all patients have completed the first six-month treatment period.

“We anticipate announcing topline results in January 2023,” ​said Nadav Kidron, Oramed CEO. “Being delivered orally, oral insulin mimics endogenous insulin regulation before reaching the bloodstream, providing better blood glucose control and potentially reducing risks and complications associated with injectable insulin, including weight gain and hypoglycemia, while also being easier to administer.”

Innovation in biologics delivery

Oramed scientific advisor, Dr Roy Eldor, who is also director of the diabetes unit, at the Institute of Endocrinology, Metabolism & Hypertension, Tel-Aviv Sourasky Medical Center, will talk about the development of the oral diabetes capsule as part of BioPharma-Reporter’s online webinar on innovation in biologics delivery on May 19.

Don't miss out. Register for that free to access event​ now.

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