Jaguar Animal Health, Inc announced earlier this month that the U.S. Patent and Trademark Office (USPTO) has issued Notices of Allowance in two pending patent applications for NP-500, licensed exclusively by the Company for veterinary use.
NP-500 is the active pharmaceutical ingredient (API) in candidates for drug products to treat and manage diseases related to equine insulin-resistance, potentially including deadly equine laminitis.
Derived from a North American plant, NP-500 has been through Phase 2 human clinical testing by third parties. Its mechanism of action has been shown to have a multitude of positive metabolic effects in animal models: the ingredient is shown to increase insulin sensitivity, reduce the levels of blood glucose, serum free fatty acids and triglycerides, and provide a potential benefit for blood pressure. The plant has been used in traditional medicine as well; it is typically brewed as a tea and used for the treatment of Type II diabetes and other various human illnesses. In March 2014, the Company filed an investigational new animal drug application (INAD) for NP-500 for metabolic syndrome in horses.
The two NP-500 pending patent applications were submitted to the USPTO by Napo Pharmaceuticals, Inc. (Napo) in April 2011. Per the terms of a license agreement between Jaguar and Napo, Jaguar has an exclusive license to these and other specified Napo intellectual property for all veterinary treatment uses and indications for all species of animals except humans.
In horses, insulin resistance is associated with an equine metabolic syndrome(EMS); EMS is characterized by obesity, increased adipose(fat) tissue that typically settles in the crest of the horse’s neck, and elevated triglycerides. It is also known to be a risk factor for laminitis and founder. Various studies report insulin resistance is prevalent in 10% in horses and 28% in ponies. There are currently no FDA-approved products for the treatment of metabolic syndrome in horses or ponies.
“We remain committed to leveraging our broad intellectual property portfolio and robust pipeline of products that have extensive safety and disease model testing in both animals and man to identify opportunities to develop species-specific, first-in-class products for markets that can be readily accessed and have treatment gaps,” explained Lisa Conte, Jaguar’s president and CEO. “Insulin resistance and the clinical manifestations of such are a significant problems in dogs, horses and cats, and we plan to initiate clinical studies for NP-500 in 2016 and beyond.”