Jaguar Health announces results of investigator-initiated studies of crofelemer

Jaguar Health family company Napo Pharmaceuticals announced that the results of two independent investigator-initiated studies of crofelemer, Napo’s novel, plant-based oral prescription drug, showed a benefit in patients with chronic refractory diarrhea and have been accepted for poster presentations at the American College of Gastroenterology Annual Scientific Meeting, which takes place October 25-30, 2024 at the Pennsylvania Convention Center in Philadelphia. Investigator-Initiated Study in Functional Diarrhea: Crofelemer significantly decreased stool consistency and abdominal pain without significant side effects, including constipation, in this small crossover study of 18 patients with functional diarrhea. The study showed that crofelemer may be a particularly useful option in those patients without a significant pain component to their symptoms, and it may be safe and effective in functional diarrhea, particularly given that its mechanism of action is not constipating. Larger trials are needed to more thoroughly assess safety and longer-term efficacy of crofelemer in functional diarrhea. Judy Nee, MD, was the principal investigator for the study. Dr. Nee is a gastroenterologist at Beth Israel Deaconess Medical Center and an assistant professor at Harvard Medical School. She serves as co-director of the GI Motility Lab at Beth Israel, and specializes in GI motility disorders and functional GI diseases such as IBS, chronic diarrhea, and constipation, as well as movement disorders of the esophagus. Functional diarrhea, defined as chronic diarrhea for more than 6 months, is a common diagnosis without effective treatments. It is a functional gastrointestinal disorder, meaning it occurs without any other known signs of disease, injury, or structural problem. Patients participating in the study self-reported their daily overall stool consistency based on the Bristol Stool Form Scale and number of loose/watery bowel movements, together with their score for their worst abdominal pain, the score for their abdominal discomfort, and any bloating episodes. The study protocol defined a stool consistency endpoint responder as a patient having less than or equal to 50% days with BSFS type greater than 5, during the prior week compared to the last week of the baseline period. Investigator-Initiated Study in Chronic Idiopathic Diarrhea: Chronic idiopathic diarrhea is a common complaint of patients presenting to family practitioners and internists, and is one of the most common reasons for referral to gastroenterologists. It is estimated that the prevalence of chronic idiopathic diarrhea in developed countries is approximately 3-5%. It has a significant negative effect on health-related quality of life and causes a high economic burden on patients and society. The study prospectively recruited patients with chronic idiopathic diarrhea defined as 3 non-bloody loose/watery stools per day or more than 20 non-bloody loose/watery stools per week for greater than or equal to 4 weeks, which corresponds to a stool consistency BSFS score of 6/7 for greater than 50% of their daily or weekly stools. Primary response was defined as a 50% decrease in mean BSFS 6/7 stool count per week by the end of week 4, and secondary response was defined as a decrease in average stool consistency by more than 2 levels in the BSFS from baseline to the end of treatment. Using this binary outcome, 58.8% of patients improved with crofelemer within the 4-week crofelemer treatment period.