US Pharm. 2018;43(10):4.

Diabetes might not be the only disease that benefits from the addition of insulin, research indicates. The work, a collaboration between departments at the University of Copenhagen and Roskilde University, promises that treating chronic bowel inflammation is possible, demonstrated by injecting insulin into the rectums of test mice.

The study, published recently in the Journal of Crohn’s and Colitis, analyzed the effect of the treatment in tests on mice with a type of ulcerative colitis. The cause of the bowel disorders is unknown, but they generate great discomfort, variously resulting in bloody diarrhea, anemia, stomachache, and weight loss in approximately 20,000 patients in Denmark who suffer from this affliction.

“Existing treatments attack the bowel’s immune system, dampening it; instead our method strengthens the bowel cells’ own defense. It appears to work equally well, and it can probably be used in combination with existing treatments,” says Jørgen Olsen, treatment codeveloper and professor at the Department of Cellular and Molecular Medicine, University of Copenhagen.

The scientists employed a variety of methods to investigate the effect of the insulin treatment. Initially, results showed that the amount of inflammation, expressed as the level of the marker Cox2, dropped by 50% compared to the saltwater control treatment.

Next, the researchers measured the body weight of the mice (people suffering from colitis typically lose a lot of weight because the disease impacts their eating habits). With the new insulin treatment, the test mice lost 15% to 20% less weight than the control group; after the insulin treatment regimen, they gained weight 50% faster.

The insulin treatment is effective, the researchers believe, because it activates a gene inside the bowel cells that has an antioxidant effect that may protect the bowel cells from inflammation.

Buoyed by the positive results, the researchers have set up a company to examine the treatment in clinical trials on humans and, potentially, to offer the technology to patients. Teaming up with the University of Copenhagen, the researchers have also applied for a patent on the innovative treatment method. (The patent application has been published and will be processed by the European and U.S. patent authorities.) In addition, the researchers’ company and the University of Copenhagen are currently negotiating a license agreement governing commercial exploitation of the patent.

Professor Olsen says that the researchers hope to initiate the phase I trials and are currently looking for investors willing to help them once they are ready for phases II and III. Because rectal injection with existing drugs is a method that is already being used in patients with bowel disease, and since insulin is already a widely approved drug for diabetes patients, they expect fast regulatory approval.

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