Invention:
This technology is a new, orally administered pro-drug form of 5-aminosalicylic acid (5-ASA) that has been developed and successfully demonstrated. This invention relates generally to the field of medicine, and more specifically to methods and compositions for targeted delivery of substances to the lower GI tract. The invention has particular utility for delivery of drugs for treating or preventing diseases of the colon, and in particular, inflammatory bowel disease and irritable bowel syndrome and will be described in connection with such utility, although other utilities are contemplated.
Background:
Millions of people in the world suffer from inflammatory bowel disease (IBD). IBD is a collective term used to describe two gastrointestinal disorders of unknown etiology; Crohn’s disease (CD) and ulcerative colitis (UC). Both diseases appear to result from the unrestrained activation of an inflammatory response in the intestine. Ulcerative colitis occurs in the large intestine, while Crohn’s disease can involve the entire gastrointestinal tract, as well as the small and large intestines. It has been suggested that the pathogenesis of IBD is multifactorial involving susceptibility genes and environmental factors. Although the causative triggers remain unclear, the role of a persistent and likely dysregulated mucosal immune response is central to the pathogenesis of IBD. It remains unclear whether the persistent inflammation, an intrinsic feature of IBD, reflects a primary aberration in mucosal response or results from an inappropriate persistent stimulation.
Advantages:
- Methods and compositions for targeted delivery of substances to the lower GI
- Two independent studies verified that the novel pro-drug, administered in a dose calculated to result in an equimolar 5-ASA yield, outperformed sulfasalazine in terms of protection from mucosal inflammation and T cell activation
- A separate study established that 5-ASA appeared in feces produced 24-48 hours following administration of the pro-drug
Applications:
- Delivery of drugs for treating or preventing diseases of the colon
- Treats or prevents inflammatory bowel disease and irritable bowel syndrome
Status: Issued U.S. Patent #9,415,110
