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- Jaguar Health's Napo Pharmaceuticals announced acceptance of two late-breaking abstracts at ESPGHAN demonstrating safety and effectiveness of liquid oral crofelemer for pediatric intestinal failure patients. - Crofelemer showed reductions in parenteral support needs for patients with microvillus inclusion disease (MVID) and short bowel syndrome, with one infant treated for over 6 months and other patients for over 1 year. - The company has completed enrollment for a randomized clinical trial in pediatric MVID patients with plans for NDA filing in mid-2027, targeting a rare disease affecting approximately 200 patients globally. - MVID patients treated with crofelemer demonstrated weight and height gains while requiring reduced parenteral support, potentially improving quality of life and reducing TPN-associated complications.
- Jaguar Health announced abstract submission for preliminary data from a US investigator-initiated trial evaluating crofelemer in adult patients with short bowel syndrome with intestinal failure (SBS-IF). - The study focuses on reducing dependence on parenteral support, a critical unmet need for SBS-IF patients who require life-sustaining intravenous nutrition up to 20 hours daily. - Previous trial results in pediatric patients showed crofelemer reduced parenteral support needs by 12-37%, supporting continued evaluation of the drug for intestinal failure conditions. - SBS-IF represents the second orphan disease indication for Jaguar's intestinal failure program, following microvillus inclusion disease (MVID) which received FDA meeting support for expedited approval.
- Jaguar Health's Italian subsidiary has submitted a request to the European Medicines Agency seeking scientific advice for EU approval of Canalevia to treat general diarrhea in dogs based on a 200-dog study from 2017. - The plant-based drug crofelemer showed significantly better outcomes than placebo in an updated analysis, with dogs experiencing fewer watery stools and improved fecal scores after treatment. - The EMA will have 60-90 days to review the data and determine if it supports approval, potentially opening access to a market of 69.4 million dogs across 27 EU member countries. - Currently no FDA-approved drugs exist to treat general diarrhea in dogs, which represents the second most common reason for veterinary emergency hospital visits.
- The FDA has authorized two expanded access programs using Jaguar Health's novel crofelemer powder to treat pediatric patients with microvillus inclusion disease (MVID), an ultrarare condition affecting approximately 200 patients worldwide. - Initial proof-of-concept results show crofelemer reduced total parenteral nutrition requirements by up to 27% in MVID patients and 12.5% in short bowel syndrome patients in ongoing investigator-initiated trials. - The botanical drug, extracted from Amazon rainforest trees, represents a potential breakthrough for conditions with no approved treatments, with patients currently requiring TPN for up to 20 hours daily. - Additional clinical data is expected in 2025 and 2026, with potential for expedited regulatory pathways including FDA Breakthrough Therapy designation if early results prove successful.
- Jaguar Health's subsidiary Napo Pharmaceuticals has submitted an orphan drug designation application to the FDA for crofelemer to treat diarrhea in breast cancer patients with brain metastasis receiving targeted therapy. - The FDA has previously recognized breast cancer with brain metastasis as a distinct orphan condition, awarding seven orphan drug designations for various therapies between 2015 and 2024. - Crofelemer, a botanical drug derived from Amazon rainforest trees, has already received orphan drug designations for other conditions in both the US and EU. - The company plans to seek Breakthrough Therapy or Fast Track designation to expedite regulatory pathways for this indication.
- Jaguar Health announced statistically significant responder analysis results for a breast cancer patient subgroup in its recently completed Phase 3 OnTarget trial of crofelemer. - The company is scheduled to meet with the FDA in May 2025 to review these positive results and discuss the regulatory pathway forward. - The estimated US metastatic breast cancer population potentially qualifies as an orphan population, aligning with Jaguar's focus on rare diseases. - Jaguar plans to pursue authorization for an expanded access program for breast cancer patients who may not be eligible for a potential pivotal treatment trial.
- A new comprehensive report analyzing the global clinical trial landscape for Chemotherapy-Induced Diarrhea (CID) has been released, providing crucial insights for stakeholders in pharmaceutical R&D. - The report details trial distribution across G7 and E7 countries, enrollment trends over five years, and classifies trials by phase, status, endpoint status, and sponsor type. - Key companies involved in CID therapeutics include Novartis AG, Jaguar Health, and Guangzhou Zhiyi Biotechnology, with the report drawing data from over 80 clinical trial registries worldwide.
- Jaguar Health has established the first study site for its field study of Canalevia-CA1, the FDA conditionally approved prescription drug for treating chemotherapy-induced diarrhea in dogs. - The company is pursuing two parallel goals: obtaining full FDA approval for CID treatment and expanding crofelemer's indication to treat general, non-infectious diarrhea in dogs. - Approximately 1 in 4 dogs develop cancer during their lifetime, with roughly 6 million new cancer diagnoses made in dogs annually in the U.S. - Jaguar is actively seeking partnerships to fund development and commercialization of crofelemer for general canine diarrhea treatment, representing a significant unmet medical need.
- Jaguar Health's Napo Pharmaceuticals will present significant results from its Phase 3 OnTarget study showing crofelemer's effectiveness in preventing diarrhea specifically in breast cancer patients receiving targeted therapy. - The FDA has granted Napo a Type C Meeting in Q2 2025 to discuss the positive responder analysis in the breast cancer subgroup, which comprised 183 of the 287 total participants in the pivotal trial. - While the initial OnTarget study did not meet its primary endpoint across all tumor types, subgroup analysis revealed statistically significant benefits for breast cancer patients, potentially addressing a critical side effect that often leads to cancer treatment modifications.
- The FDA has granted orphan-drug designation to crofelemer for treating diarrhea in cholera, a rare condition in the U.S. - This designation provides Jaguar Health with development incentives, including tax credits and marketing exclusivity. - Crofelemer is also being investigated for short bowel syndrome and microvillus inclusion disease, with potential EU access. - Jaguar Health plans to pursue orphan-drug designation for NP-300, a second-generation anti-secretory agent, for cholera.
