Jaguar Health Submits Clinical Trial Applications for Crofelemer for MVID and SBS in Europe

Jaguar Health, Inc. (NASDAQ:JAGX) has announced that its subsidiary companies, Napo Pharmaceuticals and Napo Therapeutics, have taken significant steps towards advancing their novel plant-based prescription drug, crofelemer, by submitting Clinical Trial Applications (CTA) to health authorities in Italy and Germany. These CTAs propose the initiation of a phase 2 clinical trial aimed at treating short bowel syndrome (SBS) with intestinal failure in adults. Additionally, Napo Therapeutics has submitted a CTA to AIFA, the Italian health authority, for a clinical trial targeting pediatric patients suffering from microvillus inclusion disease (MVID). An approval request for this trial is also being processed in the United Arab Emirates through the Dubai Health authority. This MVID clinical trial is conducted under an active US Investigational New Drug (IND) application in the United States.

Jaguar Health's president and CEO, Lisa Conte, expressed satisfaction with the submission of these CTAs, emphasizing that this marks a critical regulatory milestone in their ongoing efforts to develop a novel powder formulation of crofelemer for oral solutions. This formulation aims to alleviate the symptoms of MVID and SBS with intestinal failure—both of which are rare and severe diseases requiring intensive parenteral nutrition and support.

Jaguar Health, with significant contributions from Napo Pharmaceuticals and Napo Therapeutics, is also backing investigator-initiated proof-of-concept studies of crofelemer for MVID and SBS with intestinal failure in several regions including the US, EU, and the Middle East/North Africa (MENA). The results from these studies are anticipated in 2024. Notably, in August 2023, the FDA activated Napo Pharmaceuticals' IND application for a new formulation of crofelemer to treat MVID, allowing the commencement of a planned US-based phase 2 trial for pediatric MVID patients. Conte mentioned that in line with specific EU countries' guidelines, data from clinical investigations in MVID and SBS could facilitate early patient access to crofelemer for these debilitating conditions.

MVID is an extremely rare congenital diarrheal disorder that manifests as severe diarrhea, malabsorption, and acid/base instability in infants. This condition necessitates extensive parenteral support for nutrition and fluid management, with no currently approved drug treatments. Similarly, SBS patients with intestinal failure often require parenteral nutrition ranging from a few days to an entire week. The condition is associated with high morbidity and mortality rates, as well as significant medical costs. SBS patients also suffer from severe chronic diarrhea, which can lead to life-threatening dehydration, metabolic acidosis or alkalosis, malnutrition, and other secondary symptoms.

Jaguar Health, Inc. is a pharmaceutical company that focuses on developing novel, proprietary prescription medicines derived sustainably from plants, aimed at treating gastrointestinal distress in both humans and animals. This includes conditions characterized by chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Napo Pharmaceuticals, a member of the Jaguar Health family, is dedicated to developing and commercializing human prescription pharmaceuticals for managing neglected gastrointestinal symptoms across various complicated diseases. Their drug product candidate, crofelemer, is currently under a pivotal Phase 3 clinical trial, known as the OnTarget study, for the preventive treatment of chemotherapy-induced overactive bowel in adults with cancer undergoing targeted therapy. Napo Therapeutics, established in Milan, Italy, in 2021, focuses on expanding access to crofelemer in Europe, particularly for orphan and rare diseases.

Magdalena Biosciences, a joint venture between Jaguar Health and Filament Health Corp., is committed to developing new plant-derived prescription medicines for mental health indications.