Oramed starts phase 2A trials on insulin capsulesYesterday Oramed Pharmaceuticals announced they are starting phase 2A trials on their oral insulin capsules.
The capsules are being tested at Hadassah Medical Center in Jerusalem on 10 patients with type 2 diabetes.
Phase 2 is where potential drugs are tested to see if they're safe and they work (efficacy). The capsules will need to complete a phase III trial before they can be sold to people with diabetes.
The main challenge to taking insulin by mouth is that the insulin protein is broken down in the stomach before it has a chance to be used by the body. Oramed claims to have solved this problem and the challenge of getting the insulin through the walls of the intestine.
According to their website
Prof. Hanoch Bar-On, a leading Diabetologist on the Oramed team, states that the route of the insulin from the swallowed capsule “imitates nature” in that it passes to the liver and then to the bloodstream. Injected insulin goes straight to the bloodstream.I've been unable to get any information on dosing (figured out in phase 1B) or the duration of insulin delivered by the Oramed capsule. I hope to get this after phase 2A is completed. It took Oramed about seven weeks to complete phase 1B, so this information may be available sometime after mid-June.
Oramed is planning to get approval first in the US and then Europe.
In addition to their oral insulin capsule, Oramed is also working to develop an insulin suppository. This product is in Phase 1 trials at present.
Update: I exchanged some e-mails with Oramed. They told me that the phase 2a trials are 'expected to last a few months'. Also that while the trials are on people with type 2 diabetes the product may be usable by people with type 1. I'll post again once I have more news.