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Jaguar Health Announces Completion of Third-party, Investigator-Initiated Study of Crofelemer, which is Expected to Support Orphan Drug Designation (ODD) for Crofelemer for Congenital Diarrheal Disorders (CDD)
Study results expected to be described in upcoming presentations and publicationsCDD patients face intestinal failure (IF), similar to patients suffering from
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Study results expected to be described in upcoming presentations and publicationsCDD patients face intestinal failure (IF), similar to patients suffering from short bowel syndrome (SBS) - the priority focus for ODD development for crofelemerSAN FRANCISCO, CA / ACCESSWIRE / February 1, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) and Napo Pharmaceuticals, the company's wholly owned subsidiary, today announced the completion of a third-party, investigator-initiated preclinical enterocyte (intestinal cell) in vitro study to evaluate the effects of crofelemer,Napo Pharmaceuticals' plant-based prescription drug, on certain genetic defects that result in specific forms of congenital diarrheal disorders. Jaguar Health believes that these study results will support certain requests received from the Office of Orphan Products Development at the U.S. Food and Drug Administration (FDA) in response to the Orphan Drug Designation (ODD) application Napo Pharmaceuticals filed with the FDA for crofelemer for congenital diarrheal disorders (CDD) in infants and children.\"We believe the data from this study will support the rare disease business model that Napo Therapeutics, the majority owned company Jaguar Health established in Italy in 2021, is pursuing in Europe under its exclusive license for crofelemer from Jaguar Health,\" said Jaguar Health president and CEO, Lisa Conte, who is also the chairman of the board of Milan, Italy-based Napo Therapeutics S.p.A.Napo Therapeutics' mission is to provide access to crofelemer in Europe to address significant rare/orphan disease indications, including, initially, CDD and short bowel syndrome with intestinal failure (SBS-IF). Napo Therapeutics has been granted ODD for crofelemer for short bowel syndrome (SBS) in the European Union by the European Medicines Agency, and Napo Pharmaceuticals has been granted ODD for crofelemer for SBS in the U.S. by the FDA.\"CDD patients have intestinal failure and morbidity resulting in a failure to thrive due to malabsorption of nutrients and need parenteral nutrition. We believe the novel mechanism of action of crofelemer may have considerable potential to manage the severe secretory loss of electrolytes and fluid resulting in dehydration. There are currently no therapies for CDD except parenteral nutrition. Thus, crofelemer may reduce the associated morbidity and mortali...