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Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar"), under its Jaguar Animal Health tradename for the veterinary market, today announced that it has received notice from the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) of a $250,000 grant. Canalevia, under the name Canalevia-CA1, is currently conditionally approved for chemotherapy-induced diarrhea (CID) in dogs. The grant would support a confirmatory study required for full FDA approval of Canalevia (crofelemer delayed-release tablets) for the treatment of CID in dogs. Acceptance of the award is dependent upon the company's compliance with FDA terms and conditions. The company has not yet accepted the award.
"When an animal drug receives conditional approval, the CVM requires that a confirmatory trial take place within 5 years to provide the substantial evidence of effectiveness required for full approval of the drug for the indication," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies. "As announced, enrollment has begun in our ongoing full effectiveness study of Canalevia-CA1 for the treatment of CID in dogs. Although we submitted the application for this grant in June 2024, notifications of successful grant awards were delayed due to the new federal administration and funding modifications by the National Institutes of Health. We are planning to request approval from the CVM to use the grant to support this ongoing, slightly modified, field study in dogs undergoing chemotherapy."
"Looking forward, as announced, Jaguar is in discussions with multiple potential animal health company partners regarding collaborating on the development, approval, and commercialization of Canalevia for the expanded indication of treatment of general diarrhea in dogs," said Lisa Conte, Jaguar's Founder and CEO. "Our objective is to partner with an animal health company to achieve three parallel goals for Canalevia: Expand the U.S. indication from CID in dogs to treatment of general diarrhea in dogs; obtain approval in the European Union for Canalevia for treatment of general diarrhea in dogs based on existing Jaguar study data; and maintain continuity of availability in the U.S. of Canalevia for treatment of CID in dogs."
Posted In: JAGX
