What New GI Therapies Are Being Developed for Pancreatitis?

The incidence of both acute and chronic pancreatitis is rapidly increasing in the United States, partially due to rising rates in obesity. In fact, acute pancreatitis is one of the most common reasons for gastrointestinal (GI) disease-related hospitalization in the U.S., costing approximately US$2.6 billion each year. Pancreatitis occurs when digestive enzymes produced by the pancreas end up causing inflammation in the organ itself. Although this inflammation is reversible in acute pancreatitis (AP), chronic pancreatitis (CP) is a progressive condition that causes recurrent episodes and permanent scarring over time.

Patients who are at a higher risk of developing pancreatitis often also have a history of gallstones, chronic alcohol use, Crohn’s disease, diabetes, hypertriglyceridemia, or cystic fibrosis. Clinicians can manage the disease with surgical interventions, antibiotics, fluid hydration, bowel rest, and pain control, but there are currently no pharmacologic treatments available. Despite this, there are numerous recent and ongoing GI trials being conducted by biopharma sponsors and contract research organizations (CROs) to pursue drug discovery in this field. To learn about five promising pancreatitis therapies undergoing clinical trial testing, read more below!

Adrulipase | NCT05719311 (Phase 2)

Addressing exocrine pancreatic insufficiency (EPI) is often a common goal in pancreatitis and Crohn’s disease trials. Adrulipase is a recombinant lipase enzyme that has been designed as an oral microgranule capsule to allow its rapid release into the small intestine to help patients with EPI digest food more effectively. This delayed-release formula has the potential to significantly lower the number of pills pancreatitis patients often need to take to aid in food digestion daily. Pancrelipase, a similar enzyme, was also previously also studied and has been approved by the Food and Drug Administration for treating EPI in AP and CP in 2009 and 2012, respectively.

Pentoxifylline | NCT02487225 (Phase 3)

Pentoxifylline, a phosphodiesterase inhibitor, is normally used to treat muscle pain and improve peripheral circulation, but it has shown potential in reducing the damage seen in AP. The drug works to restore the function of acinar exocrine glands and promote antioxidant activities in the digestive system. Pentoxifylline’s anti-inflammatory properties may help reduce morbidity during hospitalization for moderate-to-severe pancreatitis cases.

Indomethacin | NCT02692391 (Phase 3)

AP is the most common postoperative complication of endoscopic retrograde cholangiopancreatography (ERCP). Non-steroidal anti-inflammatory drugs (NSAIDs), the most potent being indomethacin, are one of the few treatments which have shown efficacy in controlled clinical trials for preventing post-ERCP AP (PEP) [9]. Current studies are also exploring its potential for slowing disease progression in milder AP and mitigating the risk of organ failure or death.

Total Pancreatectomy and Islet Auto-Transplantation | NCT01702051 (Phase 2/3)

CP is characterized by constant, persistent abdominal pain, and unlike with AP, cannot be managed solely with nutritional intervention and symptom management. One possible treatment is the complete removal of the pancreas to cure the disease; however, a total pancreatectomy (TP) also means introducing diabetes because the patient will lose their ability to produce insulin. To get around this, surgeons can harvest islet cells from the pancreas before its removal and auto-transplant them into the liver to retain the patient’s ability to produce insulin. Although there is still a risk of diabetes, combining surgical TP with an islet auto-transplant has the potential to cure the pain of CP.

Triamcinolone | NCT00658736 (Phase 3)

CP patients have very few options to help with abdominal pain management beyond opioids and other analgesics. For decades, clinicians have been delivering an injection of anesthetic drugs into the celiac plexus, a collection of nerves near the abdomen, for relief. However, because the effects are typically short-lived, implementing injections of corticosteroids like triamcinolone has been recently investigated to provide more long-term treatment of pain lasting a few months.

The Vial GI CRO

Vial is a full-service GI CRO that recognizes the central role of technology in the future of drug development in gastroenterology and is paving the way for modernized clinical research through digital innovation. Trusted by leading sponsors, our specialized teams deliver shorter study timelines, quality affordable services, and a clinical trial experience that puts you first. Contact a team member today to discover how we can help.

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