IFALD (intestinal failure associated liver disease) is a potentially fatal liver disease that afflicts people who survive by receiving parenteral nutrition (PN). Through PN, patients with a missing or nonfunctional gastrointestinal tract receive the nutrition needed to support life. Up to 65% of all PN patients develop IFALD, in part due to deficiencies and imbalances in PN ingredients. There are as many as 25,000 PN patients in the US and ~10,000 in the EU. IFALD is characterized by accumulation of triglycerides in the liver leading to liver injury, cholestasis, and eventually a need for dual liver/intestine transplant, or death. There are no approved therapies for IFALD.
IV CHOLINE CHLORIDE
Our first program, IV Choline Chloride, has shown promising results in two Phase 2 studies in IFALD (Intestinal Failure Associated Liver Disease). IV Choline is a replacement therapy for patients on PN with choline deficiency who exhibit symptoms of liver impairment. We are developing IV Choline in partnership with Dr. Alan Buchman, a leader in the field of gastroenterology and a key voice for the potential of choline as a therapy for patients with IFALD.
ArTara’s IV Choline Chloride is protected by intellectual property through 2035 and has been awarded Orphan Drug Designation by the US FDA. Other intellectual property protections are in process, as well as Orphan Drug Designation applications in other key geographies.