Rare disease indications are the sole focus of Napo Therapeutics, the company founded by Jaguar in Italy in 2021, with an initial focus on short bowel syndrome
Jaguar is taking the lead in microvillus inclusion disease in the US, with the company aiming to submit an Investigational New Drug (IND) application to the FDA in H1 2023 for this extremely rare disease
SAN FRANCISCO, CA / ACCESSWIRE / January 26, 2023 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today announced updates regarding the Company’s focus on indications for rare and rare diseases: Short Bowel Syndrome (SBS), Microvillus Inclusion Disease (MVID) and Cholera . Rare disease indications are the sole focus of Napo Therapeutics, the company founded by Jaguar in Italy in 2021, with an initial focus on SBS. Jaguar is the majority shareholder of Napo Therapeutics.
Microvillus Inclusion Disease (MVID)
The Company intends to file an Investigational New Drug (IND) application for Crofelemer, the Company’s oral botanical, for the indication MVID with the U.S. Food and Drug Administration (FDA) in the first half of 2023 to submit, an extremely rare congenital diarrhea disorder (CDD) condition. MVID is a life-threatening autosomal recessive disease that affects neonates and children, leading to significant morbidity and even death from severe secretory diarrhea. MVID is a subgroup of different CDDs, which is a group of inherited chronic enteropathies characterized by a heterogeneous etiology, and each type of CDD is therefore a different disease with a different pathogenetic mechanism. CDDs share a primary common symptom of severe chronic diarrhea that can produce secondary symptoms including severe dehydration, metabolic acidosis or alkalosis, and malnutrition that can become life-threatening.
As previously announced, the Company has submitted an application to the FDA for Orphan Drug Designation (ODD) for MVID and is awaiting a response to the application. The orphan drug…