Benzinga | May 18, 2021 08:40AM EDT

Jaguar Health Provides Updates On Canalevia; Says If Conditionally Approved, Canalevia Will Be Available By Q4

Canalevia would be first and only FDA-approved plant-based medicine for dogs that suffer from diarrhea during chemotherapy

Canalevia will be available by fourth quarter 2021, if conditionally approved

SAN FRANCISCO, CA / ACCESSWIRE / May 18, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today provided updates regarding the development program for the Company's oral plant-based drug candidate Canalevia(tm) (crofelemer delayed-release tablets) to treat chemotherapy-induced diarrhea (CID) in dogs and exercise-induced diarrhea (EID) in dogs. There currently is no FDA-approved anti-secretory prescription product to manage these types of debilitating diarrhea in dogs.

"We are pleased to report our progress on Canalevia, which has the potential to help thousands of dogs experiencing diarrhea due to chemotherapy," said Michael Guy, DVM, Ph.D., Jaguar's vice president of preclinical and nonclinical studies. "With feedback from the FDA's Center for Veterinary Medicine (CVM), we've completed the submission of updated versions of required minor and major technical sections of Jaguar's application for conditional approval of Canalevia for CID under The Minor Use and Minor Species (MUMS) Animal Health Act of 2004. We are planning for the expected regulatory approval and commercialization of Canalevia under conditional approval for CID in the fourth quarter of 2021."

"Management of this type of debilitating diarrhea in dogs undergoing cancer treatment is a comfort issue for dogs. Additionally, diarrhea management may also help dogs better tolerate their chemotherapy and improve the home and living environment for dog owners," said Lisa Conte, Jaguar's president and chief executive officer and parent of two Jack Russell Terriers. "We are excited to report our progress on this first-of-its-kind medicine and believe Canalevia will be an important treatment option for veterinary healthcare teams and dog owners once approved."

The Company is also in the process of completing the submission package for EID for regulatory approval and commercialization in the same time frame. Working dogs, including search and rescue, military, and sled dogs, often suffer diarrhea as a result of engaging in long periods of intense, off-leash exercise.

"Elite athletes of all species tend to have more diarrhea than their healthy but more sedentary counterparts, which can interfere with peak physical performance," said Dr. Michael Davis, DVM, Ph.D., DACVIM, DACVSMR, a veterinary physiologist and board-certified specialist in veterinary internal medicine and veterinary sports medicine at Oklahoma State University, where he conducts research on animal exercise physiology and performance. "There is a significant need in the world of working dogs for a safe and effective medicine that can reduce the incidence and severity of exercise-induced diarrhea without affecting performance."

According to current estimates, more than 230,000 dogs in the U.S. receive chemotherapy treatment for various cancers each year, and roughly one in four (more than 50,000 dogs) will experience diarrhea as a side effect of treatment. Jaguar estimates that 5,000 to 15,000 dogs in the U.S. experience EID annually.

Jaguar's wholly owned subsidiary, Napo Pharmaceuticals, Inc., currently markets a form of crofelemer, Mytesi(r), which is the only non-opioid oral plant-based medicine approved by the FDA for the treatment of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Crofelemer, derived from the Croton lechleri tree, is responsibly and sustainably harvested in South America. Napo is pursuing the development of Mytesi to treat cancer therapy-related diarrhea in humans.

As previously announced, Jaguar has received Minor Use/Minor Species (MUMS) Designation for Canalevia for CID in dogs. Jaguar will also be applying for MUMS Designation for Canalevia by the end of May 2021 to treat EID in dogs. To obtain conditional approval of a MUMS drug, a company must submit Chemistry, Manufacturing and Controls (CMC), Environmental Impact, and Target Animal Safety data identical to that required for a new animal drug application (NADA) as well as data suggesting a reasonable expectation of effectiveness (RxE). After the submission and the review of the application, the FDA through the CVM can then grant a conditional approval (CA-1). This approval allows for commercialization of the product while the sponsor continues to collect the substantial evidence of effectiveness required for a full NADA approval. A sponsor that gains approval or conditional approval for a MUMS-designated drug then receives seven years of marketing exclusivity.

MUMS designation is modeled on the orphan-drug designation for human drug development and offers possible financial incentives to encourage MUMS drug development, such as the availability of grants to help with the cost of developing the MUMS drug and a longer period of marketing exclusivity. The purpose of the MUMS Act is to encourage development and availability of animal drugs intended as a minor use in a major species (defined as dogs, cats, cattle, horses, chickens, turkeys and pigs) to treat diseases which occur infrequently or in limited geographic areas, and to encourage development and availability of animal drugs for use in minor species (defined as all animals other than humans that are not one of the seven major species).