Business
Jaguar Health Provides Updates Regarding Company's Focus on Rare and Orphan Disease Indications in the U.S. & Europe
Rare disease indications are the sole focus of Napo Therapeutics, the corporation established by Jaguar in Italy in 2021, with an initial focus on short bowel
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Rare disease indications are the sole focus of Napo Therapeutics, the corporation established by Jaguar in Italy in 2021, with an initial focus on short bowel syndromeJaguar to take the lead on microvillus inclusion disease in the U.S., with the Company intending to submit an Investigational New Drug (IND) application to the FDA for this ultra-rare disease in 1H 2023SAN FRANCISCO, CA / ACCESSWIRE / January 26, 2023 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the \"Company\") today provided updates regarding the Company's focus on rare and orphan disease indications: short bowel syndrome (SBS), microvillus inclusion disease (MVID), and cholera. Rare disease indications are the sole focus of Napo Therapeutics, the corporation established 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 submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the first half of 2023 for crofelemer, the Company's oral botanical drug, for the indication of MVID, an ultra-rare congenital diarrheal disorder (CDD) condition. MVID is a life-threatening autosomal recessive disease that affects newborns and children and leads to significant morbidity and even death from severe secretory diarrhea. MVID is a subset of various CDDs, which 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 of severe chronic diarrhea, which may produce secondary symptoms, including significant dehydration, metabolic acidosis or alkalosis and malnutrition, which may become life-threatening.As previously announced, the Company has submitted an Orphan Drug Designation (ODD) application to the FDA for MVID and is awaiting a response on the application. The Orphan Drug Act of 1983, a law passed in the U.S. to facilitate development of drugs for rare diseases, provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. ODD qualifies the sponsor of the drug for various development incentives, including tax credits for qualified clinical testing and relief of filing fees. The Europ...