A new prescription drug being developed for animals, tapped from rainforest trees, seeks to treat chemotherapy-induced diarrhea (CID) in dogs. The company, Jaguar Animal Health), subsidiary of Napo Pharmaceuticals, Inc. (San Francisco), has received an investigational new animal drug application (INADA) number SP-303, and seeks to file an application for this indication later in the year.
Jaguar was formed in 2012 as the animal-health companion to parent Napo. Both are exclusively focused on marketing rainforest plant-derived drugs, nutraceuticals, and food supplements. SP-303, for instance, is an isolated and purified from the medicinal rainforest plant Croton lechleri. A variant native Latin American plant’s red resin, also known as dragon’s blood, gained US approval for the treatment of HIV-associated diarrhea in humans in December 2012. That drug, Fulyzaq (crofelemer), is distributed by Salix Pharmaceuticals (Raleigh, NC) under license from Napo.
Jaguar is seeking MUMS designation under FDA’s Minor Use and Minor Species Animal Health Act of 2004. The MUMS Act is an animal equivalent to the Orphan Drug Act for humans, allows a marketing channel for drugs to small populations pending completion of effectiveness data, among other conditions. There are variations in the Act that have Jaguar seeking designation and ultimate approval for a minor population of a major species, in this case fewer than 70,000 dogs suffering from CID.
Both companies seek to discover and develop human as well as animal treatments, the latter applicable to roughly 30% of those in one or the other stage of development, Lisa Conte, founder and CEO of both companies, told Pharmaceutical Commerce. Once a pure compound (drug) shows promise, it’s targeted for efficacy testing. “Some drugs make it in all species, and some drugs only make it in some species, including humans,” Conte says.
There are other treatments for watery diarrhea, but Conte says SP-303 and both companies’ other drugs in development are “first in class:” and novel because they aren’t absorbed by the bloodstream and have no interactions with other drugs or enzymatic pathways. “Our novelty is in the mechanism of action of ours that has not been developed for humans or animals before.” Jaguar and Napo together expect to file 5-6 additional INADAs for various animal and human products for gastro-intestinal, infectious metabolic diseases.