Crofelemer in Intestinal Failure
Crofelemer in Intestinal Failure
Short Bowel Syndrome with Intestinal Failure (SBS-IF)
An estimated
10,000-20,000
individuals in the US have
IF due to SBS1
Intestinal failure (IF) is defined as the reduction of intestinal function such that fluids and nutrients given by the enteral or parenteral (PN) route are needed to maintain health
Home parenteral nutrition
can cost patients
$100k-$150k
a year in the US1
SBS-IF 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 requiring parenteral nutritional support for survival
The mortality rate of SBS
patients on home parenteral
nutrition is about
30% after 5 years1
SBS patients suffer from malnutrition, dehydration, imbalances of fluids and salts, and excessive intestinal fluid output
Crofelemer’s ability to regulate ion channels in the gut normalizes the salt and water balance in the small bowel, which may lead to better absorption of fluids and nutrients in those living with SBS-IF
Research & Development
- The initial focus of Napo Therapeutics, an Italian corporation established by Jaguar Health in Italy, is on pursuing the conditional marketing authorization pathway from the European Medicines Agency for crofelemer for SBS-IF and congenital diarrheal disorders (CDD)
- Planning to complete a global trial (in collaboration with Napo Pharmaceuticals) in SBS-IF patients suitable for the conditional approval pathway in the EU
Research & Development
- The initial focus of Napo Therapeutics, an Italian corporation established by Jaguar Health in Italy, is on pursuing the conditional marketing authorization pathway from the European Medicines Agency for crofelemer for SBS-IF and congenital diarrheal disorders (CDD)
- Planning to complete a global trial (in collaboration with Napo Pharmaceuticals) in SBS-IF patients suitable for the conditional approval pathway in the EU
Orphan-Drug Designation
- Crofelemer has received orphan-drug designation in the US and European Union for SBS
- Crofelemer has received orphan-drug designation in the European Union for Microvillus Inclusion Disease (MVID), a rare congenital diarrheal disorder (CDD) condition
Orphan-Drug Designation
- Crofelemer has received orphan-drug designation in the US and European Union for SBS
- Crofelemer has received orphan-drug designation in the European Union for Microvillus Inclusion Disease (MVID), a rare congenital diarrheal disorder (CDD) condition
Congenital Diarrheal Disorders (CDD)
Rare Congenital Chronic Intestinal Channel Disease
Occurring in Early Infancy
CDD patients experience severe, lifelong diarrhea—the incidence is highest in regions where consanguineous marriage is more common
Unmet Needs
Patients endure a lifelong need for nutritional intake, either parenterally or via a feeding tube
Research & Development
- In vitro confirmation of activity required by FDA
- Jaguar is currently supporting an investigator-initiated proof-of-concept study of crofelemer in patients with SBS or CDD with intestinal failure, with a planned endpoint of reduction of requirement of weekly volume of parenteral nutrition
Reference: 1. Schalamon J, Mayr JM, Höllwarth ME. Mortality and economics in short bowel syndrome. Best Pract Res Clin Gastroenterol. 2003;17(6):931-942. doi:10.1016/s1521-6918(03)00079-9
Research & Development
- In vitro confirmation of activity required by FDA
- Jaguar is currently supporting an investigator-initiated proof-of-concept study of crofelemer in patients with SBS or CDD with intestinal failure, with a planned endpoint of reduction of requirement of weekly volume of parenteral nutrition
Reference: 1. Schalamon J, Mayr JM, Höllwarth ME. Mortality and economics in short bowel syndrome. Best Pract Res Clin Gastroenterol. 2003;17(6):931-942. doi:10.1016/s1521-6918(03)00079-9
