Jaguar Health Initiates Enrollment in Canalevia-CA1 Study for Chemotherapy-Induced Diarrhea in Dogs, Eyes EU Expansion.

Jaguar Health has initiated a study of its FDA conditionally approved prescription drug, Canalevia-CA1, for chemotherapy-induced diarrhea in dogs. The study has enrolled four dogs, and the company plans to expand to Europe, targeting a potential market of 104 million dogs, and to the US for general diarrhea treatment. Canalevia-CA1 is a plant-based, non-antibiotic drug aiming to reduce diarrhea without antibiotic resistance risks.

Jaguar Health, Inc. (NASDAQ: JAGX) has initiated a field study of its FDA conditionally approved prescription drug, Canalevia-CA1, for chemotherapy-induced diarrhea (CID) in dogs. The study, which began enrolling four dogs, aims to collect real-world data to support potential full FDA approval for the treatment of CID. The company also plans to expand the study to Europe and the U.S., targeting a significant market of 104 million dogs [1].

Canalevia-CA1, a plant-based, non-antibiotic drug, contains crofelemer, which modulates chloride channels in the gastrointestinal tract to reduce diarrhea. The drug is currently conditionally approved in the U.S. for CID in dogs and has shown promising results in a completed study of 200 dogs with general diarrhea in Europe. The study, while not meeting its primary endpoint, demonstrated significant clinical benefits when analyzed using an alternate endpoint [1].

Jaguar Health is actively seeking potential animal health company partners to collaborate on bringing Canalevia-CA1 to regulatory approval and commercialization for the treatment of general diarrhea globally. The company estimates that U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs, indicating a substantial unmet medical need [1].

The ongoing study in the U.S. is a prospective, randomized, open-label field study involving dogs undergoing chemotherapy treatment. Dogs enrolled in the study will be randomly assigned to receive Canalevia-CA1 or be placed in a control group. The study aims to collect real-world data to demonstrate the clinical effectiveness of Canalevia-CA1 for the treatment of CID in dogs [1].

Jaguar Health plans to submit a dossier to the European Medicines Agency (EMA) outlining the results of the updated analysis of the company's completed study of Canalevia-CA1 in dogs with general diarrhea. If acceptable to the EMA, the company will then submit a Marketing Authorization Application (MAA) for Canalevia-CA1 for general diarrhea in dogs. If approved, the drug will be marketable for treatment of general diarrhea in dogs in all 27 EU member countries [1].

References:
[1] https://www.jsonline.com/press-release/story/2991/enrollment-initiated-in-jaguar-health-study-of-its-fda-conditionally-approved-canalevia-ca1-prescription-drug-for-dogs/