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 (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs
- natural sciences biological sciences biochemistry biomolecules proteins
- medical and health sciences clinical medicine endocrinology diabetes
- medical and health sciences medical biotechnology tissue engineering artificial pancreas continuous glucose monitors
You need to log in or register to use this function
We are sorry... an unexpected error occurred during execution.
You need to be authenticated. Your session might have expired.
Thank you for your feedback. You will soon receive an email to confirm the submission. If you have selected to be notified about the reporting status, you will also be contacted when the reporting status will change.
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
-
H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs
MAIN PROGRAMME
See all projects funded under this programme -
H2020-EU.3. - PRIORITY 'Societal challenges
See all projects funded under this programme -
H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies
See all projects funded under this programme
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
SME-1 - SME instrument phase 1
See all projects funded under this funding scheme
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-EIC-SMEInst-2018-2020
See all projects funded under this callCoordinator
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
9370648 JERUSALEM
Israel
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.