Johns Hopkins gastroenterologist Florin Selaru and nanomedicine researcher Laura Ensign discuss their work addressing one of the major clinical problems related to inflammatory bowel disease (IBD): strictures in the gastrointestinal (GI) tract. Currently, no medications are approved by the Food and Drug Administration to treat fibrosis or strictures in the GI tract. After identifying molecules that have anti-fibrotic activity, Selaru collaborated with Ensign, who designed a sustained-release formulation that can be injected during an endoscopy. The formulation acts over a period of time at the site where it is intended to prevent stricture formation. Testing on animal models was successful, and the team aims to continue its work to gain FDA approval as a treatment option for patients with IBD.
I'm a Florence Cleo and I'm a gastroenterologist at Johns Hopkins University. I specialize in inflammatory bowel disease. One of the major clinical problems we have in inflammatory bowel disease is strictures in the G I tract. Strictures are also met outside of inflammatory bowel disease such as in the case of esophageal strictures and others. Currently, there are no FDA approved medications to treat fibrosis or strictures in the G I tract to address this limitation. We started a project where we identified such molecules based on a high throughput draw screen that we designed in the lab. After we found several such molecules that have an anti fibrotic activity. We started collaborating with Professor Ensign. We wanted to design a sustained release formulation. And the reason for that is because fibrosis and stricture formation is a process that takes several days to weeks. And we wanted to maintain our current procedures which involve uh endoscopy, stricture dilation and then follow up of the patient. So we wanted to have a CIST formulation that can be injected at the time of the procedure and that can act over uh several days. Uh two weeks. Hi, my name is Laura Enson, I'm a professor in ophthalmology at the Wilmer Eye Institute. I'm a biomedical engineer by training and a phd scientist. I work on nano medicine and drug delivery. Uh The concept of drug delivery is generally that we have a lot of drugs and molecules that work really well for different medical and medications. But when we take them orally or systemically, then the drug is reaching every cell in your body and can cause side effects and other kinds of toxicity that is undesirable for patients. And so we can even end up with things called those limiting side effects, such that we can't use that medication, even if it works really well in the cells that we're intending to treat. Um And so what we can do is we can take drugs and other small molecules and we can package them into nanoparticles or microparticles or other types of sustained delivery systems that we can uh introduce into the body locally to, to provide sustained release of the drug, but only at the site of action where it's intended. And so we can reduce side effects. We can actually make the medication more effective in this way and then far more convenient for the patients that are using it. Um So when Dr Cerro came to us with this need that he identified in, in IBD, it was a perfect fit for sustained release approaches. Um And this is because we don't need the drug to be in the entire body. We really want it to act locally in the intestine and then having it uh be sustained over time is really how you're going to prevent those those chronic fibrotic processes from reoccurring the successful sustained release formulation that was designed in collaboration with Professor Ensign was then tested in animal models. What we found was that those structures that were treated with the anti fibrotic that was formulated for sustained release, maintained its diameter open for longer. So therefore, the treatment was successful at addressing these strictures in the G I tract. This is a medication that can affect the lives of many patients with inflammatory bowel disease or with the strictures in the G I tract. We would like to thank the Crohn's and Colitis Foundation uh as well as the Hensley Trust for their very generous support of this project for the sustained release uh formulation uh of an anti fibrotic. Also, we would like to thank the many people who worked on the project both in uh Doctor Ensign's lab, as well as in my lab and our collaborators uh in pathology, uh surgery and ra radiology at John Hopkins University.