Project description
First oral insulin for the treatment of type 2 diabetes
Type 2 diabetes affects more than 400 million people worldwide. Almost 50 million of them are European citizens. Efficient control of blood glucose level is critical for the prevention of the disease as well as longer lifespan and higher quality of life for patients. Despite significant progress over recent decades in the treatment of type 2 diabetes, many patients depend on multiple daily insulin injections associated with social stigma, pain and high cost in case of non-adherence to the treatment. Oramed Pharmaceuticals aims to transform the treatment using proprietary technology to protect insulin in the gastrointestinal tract, opening the way to oral insulin treatment. Oramed has produced oral insulin and demonstrated its efficacy in a Phase II clinical trial with >300 patients. The EU-funded Oralis project provides additional support for a Phase III clinical trial to confirm oral drug efficacy for glycaemic control in type 2 diabetes patients.
Objective
Type 2 Diabetes Mellitus (T2DM) affects 415M people globally, 49M of them within Europe. Caring for these individuals costs Europe €181M billion annually. However, more needs to be done as T2DM and its related co-morbidities claim hundreds of thousands of lives each year in the region. The early control of blood glucose levels (BGL) is the key to the prevention of the disease, and longer lifespans with better prognosis and higher quality of life for T2DM patients.
The last century has seen considerable development in T2DM treatment, but the eventual solution to control BGL for many patients are multiple daily insulin injections. This has created a huge global market to be worth €49 billion (est. 2020). The pain, social stigma, and burden associated with injecting insulin contribute to a non-adherence to treatment that has been estimated to be as high as 61%, at a cost 9,649€ per patient per year.
Oramed Pharmaceuticals (Oramed) will transform this paradigm with its POD™ technology. It protects protein therapies like insulin from the harsh conditions in the gastrointestinal tract, allowing then to be taken orally. This opens a way into oral insulin treatment to overcome many of the issues contributing to non-adherence of injected insulin treatment in T2DM patients. Using POD™ technology Oramed has produced the first oral insulin and demonstrated its efficacy in Phase II clinical trials with >300 patients and >5000 doses. We have proven oralis capability to deliver to the liver bioavailable insulin at sufficient concentration to produce significant glucose control in all glycaemic parameters in T2DM patients. Through the SME instrument Oramed will finalise the Phase III clinical trial to confirm the efficacy of oralis for glycaemic control in T2DM patients.
We have already reach commercial agreements to commercialise oralis. Our estimation is to generate a similar revenue creation and market share as the newest injectable insulin options of €1.7 bn in 5 years.
Fields of science
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- natural sciencesbiological sciencesbiochemistrybiomoleculesproteins
- medical and health sciencesclinical medicineendocrinologydiabetes
- medical and health sciencesmedical biotechnologytissue engineeringartificial pancreascontinuous glucose monitors
Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
9370648 JERUSALEM
Israel
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.