Jaguar Health Initiates Field Study for Canalevia-CA1 in Dogs with Chemotherapy-Induced Diarrhea

Jaguar Health has established the first site for its Canalevia-CA1 field study, which aims to treat chemotherapy-induced diarrhea in dogs. The company is a commercial-stage pharmaceuticals firm focused on developing novel prescription medicines derived from plants for humans and animals with gastrointestinal distress. Its subsidiary Napo Pharmaceuticals develops and commercializes human prescription pharmaceuticals.

Jaguar Health, a commercial-stage pharmaceutical company, has established the first site for its Canalevia-CA1 field study, aiming to gather real-world data on the treatment of chemotherapy-induced diarrhea (CID) in dogs. The study is part of Jaguar's broader strategy to develop novel prescription medicines derived from plants for both human and animal gastrointestinal distress.

Canalevia-CA1, a delayed-release tablet formulation of crofelemer, received conditional approval from the U.S. Food and Drug Administration (FDA) in December 2021 for the treatment of CID in dogs. This conditional approval allows the company to legally promote and sell the drug while continuing to collect the substantial evidence required for full FDA approval. The drug is currently conditionally approved under application number 141-552.

The objective of the prospective, randomized, open-label field study is to collect real-world data demonstrating the clinical effectiveness of Canalevia-CA1 for CID in dogs. Dogs enrolled in the study will be randomly assigned to receive Canalevia-CA1 or a placebo. The study's primary goal is to support potential full FDA approval of the drug for this indication.

Jaguar Health's subsidiary, Napo Pharmaceuticals, focuses on developing and commercializing human prescription pharmaceuticals, aligning with the company's broader mission to address gastrointestinal distress in both humans and animals. The company's canine-focused business development efforts aim to expand the indication of crofelemer to treat general, non-infectious diarrhea in dogs, a significant unmet medical need.

The field study is a key milestone in Jaguar Health's efforts to expand the use of crofelemer, which is the only oral FDA-approved prescription drug under botanical guidance. The company estimates that approximately six million annual cases of acute and chronic diarrhea in dogs could benefit from a product like Canalevia-CA1, given the lack of FDA-approved drugs for canine general, non-infectious diarrhea.

Jaguar Health is currently in discussions with potential partners to fund the development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the U.S. and/or globally. The company is also exploring pathways to bring crofelemer to metastatic breast cancer patients and to expand access for cancer therapy-related diarrhea in breast cancer patients.

References:
[1] https://www.nasdaq.com/press-release/first-study-site-established-jaguar-health-study-its-fda-conditionally-approved