First patient enrolled in phase IIb Oramed insulin pill study
Israeli company Oramed has announced that it has screened and enrolled its first patient in an upcoming phase IIb trial of its oral insulin pill, currently named ORMD-0801.
The study will recruit approximately 180 patients with type 2 diabetes and test the pill for efficacy (ability to produce a therapeutic effect) and safety. Whilst this trial involves patients with type 2 diabetes, Oramed intend for their ORMD-0801 insulin pill to be of use in type 1 diabetes to help reduce the number of daily injections.
The challenge of oral insulin delivery
Despite insulin having been given as a treatment for nearly 100 years, a commercially available insulin pill has yet to be achieved. One reason for this is that the body’s digestive system breaks down insulin before it can be absorbed into the blood. A second reason is that larger proteins, such as insulin, cannot easily pass into the blood through the wall of the small intestine.
Oramed’s answer to the first problem is to have a capsule that is pH sensitive and only breaks down once within the acidity range found within the small intestine. Within the capsule, along with the insulin molecules, are protease inhibitors and an absorption enhancer. The protease inhibitors work by blocking the activity of proteases (protein degrading enzymes) to prevent the insulin being broken down. The absorption enhancers work towards helping the insulin molecules to cross through the membrane of the small intestine.
Once absorbed into the blood, the insulin can travel via the portal vein towards the liver. This better mimics the effects of insulin produced by the body.
Will the pill deliver?
A previous trial has shown ORMD-0801 to be able to reduce insulin needs in a smaller trial of 25 people with type 1 diabetes. The upcoming trial, with around 7 times as many participants, will be able to provide more statistically significant results.
There is a lot of hope for the ORMD-0801 pill but success is not guaranteed. Delivering reliable dose quantities and successfully lowering blood glucose without leading to regular hypos are some of the challenges that the pill will need to meet.
If the pill’s performance in phase IIb trials is successful, phase III trials in an even larger number of patients will be a next hurdle before the drug can be approved.
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