U.S. IIT Begins for Jaguar Health's Crofelemer in SBS-IF

Jaguar Health, Inc. (NASDAQ:JAGX), along with its subsidiary Napo Pharmaceuticals, has initiated an independent investigator-initiated trial (IIT) in the United States to evaluate the efficacy and safety of crofelemer, a novel plant-based anti-diarrheal prescription drug. This trial focuses on treating short bowel syndrome with intestinal failure (SBS-IF) in adults. Information about the study can be accessed on the ClinicalTrials.gov website.

Lisa Conte, the founder, president, and CEO of Jaguar, stated that this study is part of five clinical efforts to explore crofelemer's potential in treating rare diseases such as SBS-IF and microvillus inclusion disease (MVID). These include three IIT proof-of-concept studies and two Phase 2 studies across the US, European Union, and MENA regions. These studies are examining a new powder formulation of crofelemer for oral solution, distinct from the FDA-approved oral formulation used for HIV/AIDS patients. The initial dosing for the first patient in these studies is expected to take place from December 2024 through Q1 2025, with potential results from the IIT proof-of-concept studies anticipated by Q2 2025. Published data from these clinical trials might support early patient access to crofelemer in certain European countries.

Conte highlighted the significant impact of SBS-IF and MVID on patients' quality of life, requiring intensive parenteral nutrition (PN) and support. These conditions not only affect patients but also their caregivers. The planned Phase 2 studies aim to evaluate the quality-of-life outcomes for both patients and caregivers. SBS patients with intestinal failure often need PN up to seven days a week, which is associated with high morbidity, mortality, and medical costs. These patients also suffer from severe chronic diarrhea and related complications like dehydration, metabolic imbalances, and malnutrition, which can become life-threatening.

MVID, a congenital diarrheal disorder, is more common in cultures with consanguineous marriages, making the company's collaborations with healthcare professionals in the MENA region crucial. These relationships are reflected in the geographical recruiting of the trials. Crofelemer has received Orphan Drug Designation from both the FDA and the European Medicines Agency for treating SBS-IF and MVID.

Crofelemer, derived from the red bark sap of the Croton lechleri tree in the Amazon Rainforest, is an oral plant-based prescription medicine. Napo Pharmaceuticals has implemented a sustainable harvesting program under fair trade practices to ensure high-quality production, ecological integrity, and support for indigenous communities.

Jaguar Health, a commercial-stage pharmaceuticals company, focuses on developing novel prescription medicines derived from rainforest plants for gastrointestinal distress in humans and animals. The company’s subsidiary, Napo Pharmaceuticals, is dedicated to developing and commercializing human prescription drugs for the management of neglected gastrointestinal symptoms across various disease states. Crofelemer, under the brand name Mytesi®, is FDA-approved for noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. In 2021, Jaguar established Napo Therapeutics, an Italian corporation, to expand crofelemer's access in Europe, specifically for orphan and rare diseases. Jaguar Animal Health operates under the Jaguar tradename. Additionally, Jaguar and Filament Health Corp. have formed a joint venture called Magdalena Biosciences, which focuses on developing plant-derived prescription medicines for mental health indications.