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SBS is a complex condition characterized by severe malabsorption of fluids and nutrients due to surgical resection of bowel segments, congenital anomalies, or disease-associated loss of absorption. For SBS patients who endure the catastrophic loss of their bowel, the resulting excessive intestinal fluid output and lifelong restriction and adjustment of oral intake of food and liquids leads to the requirement to receive intravenous fluids for the majority of the day every day (parenteral nutrition). This challenges the ability of SBS patients to carry out activities of daily living and has a significant impact on their daily quality of life. Furthermore, lifelong parenteral nutrition leads to potentially life-threatening complications like sepsis and organ failure.

CDDs are a group of inherited chronic enteropathies characterized by heterogeneous etiology, and each type of CDD is thus a different disease with a different pathogenetic mechanism. CDDs share a primary common symptom: chronic diarrhea, and therefore secondary symptoms associated with diarrhea, including significant dehydration, metabolic acidosis or alkalosis and malnutrition, among other secondary symptoms, and these symptoms expeditiously emerge and become life-threatening.

Napo Therapeutics, the corporation established by Jaguar in Italy in 2021, is committed to developing solutions in this therapeutic area for which there is a high unmet medical need. In December 2021, the European Medicines Agency (EMA) granted orphan-drug designation (ODD) for crofelemer for SBS following submission of Napo Therapeutics’ ODD application, which included epidemiological data for the incidence and prevalence of SBS, data on the pathophysiology of SBS, support for the mechanistic rationale for crofelemer for SBS, medical plausibility information for crofelemer for SBS, together with preclinical pharmacology and patient case studies. Crofelemer received ODD in the U.S. for SBS in 2017.

In addition, Napo Therapeutics recently submitted an ODD application to the EMA for crofelemer for a rare CDD condition called microvillus inclusion disease (MVID). An article published June 17, 2022 in Osservatorio Malattie Rare, an Italian publication focused on rare diseases, comments on this submission and can be viewed by clicking here. MVID is a life-threatening and rare autosomal recessive disease that affects newborns and children and leads to significant morbidity and even death from severe secretory diarrhea.