OrbeShield® is a topical anti-inflammatory treatment for the stomach and intestines. OrbeShield® is the same formulation as SGX203 for Pediatric Crohn’s Disease. The active ingredient is beclomethasone 17,21-dipropionate (BDP).
BDP is a steroid which can reduce local inflammation but has limited ability to penetrate the body.
By providing a formulation of BDP which coats the inside of the gut with steroid, but isn’t absorbed into the bloodstream, the systemic side effects of steroid treatment (including increased risk of infection) are reduced.
OrbeShield® may mitigate the “inflammatory overdrive” occurring in GI ARS, allowing the recovering intestinal cells to structure themselves correctly with reduced long term side effects.
How is OrbeShield® delivered?
OrbeShield® is a combination of two pills, both containing the active ingredient BDP. One of the pills is designed to dissolve in the stomach, releasing BDP to coat the upper gastrointestinal tract. The other pill is designed to dissolve in the intestine, coating the bottom half of the gastrointestinal tract.
As an oral drug with good room temperature stability, OrbeShield® can be delivered rapidly and easily in a mass casualty context.
What is known about BDP?
Beclomethasone dipropionate (BDP) is a very well-known steroid that has been used in inhaled products for asthma, in nasal sprays for rhinitis and in skin creams for rashes. It has been used in children and adults for over 40 years. There is a lot of information known about the safety and efficacy of BDP.
Mechanism of Action
As with all corticosteroids, BDP binds to the corticosteroid receptor and has anti-inflammatory action, suppressing the infiltration of inflammatory cells to the local site of action.
The distinguishing feature of BDP is that it does not travel throughout the body easily, meaning that it has a local action without inducing as many side effects throughout the body. This also means that the BDP must be delivered directly to where it is needed – which is reflected in the unique oral formulation that is used in OrbeShield®.
In the context of radiation damage, systemic steroid use would be dangerous as it would also suppress the activity of the immune system (which is also trying to recover). However, topical application of steroids to the GI tract may both stop ongoing inflammatory damage (which may be increasing cell death in addition to the initial radiation damage) and can stop the longer term process of fibrosis (which may yield long term irreversible damage to the intestines in any survivors).
More details on the mechanism of action of OrbeShield® can be found in our Reference Literature.