New European & Australian Patents Strengthen Jaguar Health's IP for SBS and CDDs Treatment

Napo Pharmaceuticals, part of the Jaguar Health family, recently announced that it has been granted new patents by the European Patent Office and IP Australia. These patents focus on the use of crofelemer, a novel plant-based prescription drug, for the treatment of various forms of severe diarrhea. The European patent specifically addresses methods for treating conditions such as Short Bowel Syndrome (SBS), bile acid diarrhea, and diarrhea related to small intestine resection or gallbladder removal using an inhibitor of chloride-ion transport like crofelemer. Meanwhile, the Australian patent outlines methods for preventing and treating diarrhea associated with congenital diarrheal disorders (CDDs) using a proanthocyanidin polymer composition such as crofelemer.

Lisa Conte, the founder, president, and CEO of Jaguar Health, expressed satisfaction with the new patents, emphasizing their importance in enhancing intellectual property protection for crofelemer, particularly in its core target indications of SBS and Microvillus Inclusion Disease (MVID). Conte highlighted the ongoing investigator-initiated proof-of-concept studies for crofelemer in treating SBS with intestinal failure and MVID, conducted across regions including the US, EU, and Middle East/North Africa. Results from these studies are anticipated in 2024 and 2025. Additionally, clinical data from these studies could potentially support early patient access to crofelemer in specific EU countries under their respective guidelines.

SBS patients often face severe health challenges, including intestinal failure requiring parenteral nutrition (PN) multiple times a week. This condition is associated with significant morbidity and mortality, as well as high medical costs due to the need for PN. Complications include severe chronic diarrhea, dehydration, metabolic imbalances, and malnutrition, which can become life-threatening. MVID, a rare congenital diarrheal disorder, is another severe condition characterized by chronic diarrhea, malabsorption, and acid/base instability. It necessitates intensive parenteral support for nutritional and fluid management, with no approved drug treatments currently available.

Napo Pharmaceuticals holds approximately 152 issued patents and has around 43 patents pending. Crofelemer stands out as the only oral plant-based prescription medicine approved under the FDA's Botanical Guidance, offering an additional exclusivity benefit due to the complexities involved in producing a generic version of the drug.

Crofelemer is derived from the red bark sap of the Croton lechleri tree, commonly known as "dragon's blood," found in the Amazon Rainforest. Napo Pharmaceuticals has instituted a sustainable harvesting program for crofelemer, ensuring high quality and ecological integrity while supporting indigenous communities.

Jaguar Health specializes in developing proprietary prescription medicines sourced sustainably from rainforest plants. These medicines target gastrointestinal distress, particularly overactive bowel conditions such as chronic diarrhea, urgency, bowel incontinence, and cramping pain. Napo Pharmaceuticals focuses on human prescription pharmaceuticals aimed at managing neglected gastrointestinal symptoms across various disease states. Crofelemer, marketed under the brand name Mytesi®, is FDA-approved for the relief of non-infectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Additionally, it is being investigated in a phase 3 clinical trial for the prevention of cancer therapy-related diarrhea (CTD).

Jaguar Health’s Italian subsidiary, Napo Therapeutics, established in Milan in 2021, is devoted to expanding access to crofelemer in Europe, particularly for orphan and rare diseases. Another arm of Jaguar Health, Magdalena Biosciences, is a joint venture with Filament Health Corp., focusing on developing novel prescription medicines derived from plants for mental health indications.