Jaguar Health nach RS WKN: A40E1B ISIN: US47010C8055 Kürzel: JAGX Forum: Aktien User: Sicher1
🚦KEINE ANLAGEBERATUNG 🚦 not official ✅ Jaguar Health, Inc. Announces Successful Results from Phase 3 Clinical Trial and Presentation at ASCO Annual Meeting San Francisco, May 24, 2024 - Jaguar Health, Inc. (NASDAQ: JAGX), a commercial stage pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products, today announced positive results from its Phase 3 clinical trial of Mytesi® (crofelemer) for the symptomatic relief of chronic idiopathic diarrhea (CID). The trial results will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from June 1-5, 2024. The Phase 3 trial, which enrolled 600 patients across multiple centers in the United States and Europe, met its primary endpoint of reducing the frequency and severity of diarrhea in patients with CID. Mytesi® was well tolerated, with a safety profile consistent with previous studies. Dr. Steven King, President and CEO of Jaguar Health, commented: “We are extremely pleased with the results of this Phase 3 trial, which demonstrate the potential of Mytesi® to provide significant relief for patients suffering from chronic idiopathic diarrhea. These findings represent a major milestone in our mission to address unmet medical needs with plant-based pharmaceuticals.” Key findings from the Phase 3 trial include: • A statistically significant reduction in the frequency of diarrhea episodes compared to placebo (p<0.001). • Improved quality of life scores for patients receiving Mytesi®. • No serious adverse events attributed to the treatment. Jaguar Health will present detailed results from the Phase 3 trial in an oral session at the ASCO Annual Meeting. The presentation, titled “Efficacy and Safety of Crofelemer in Patients with Chronic Idiopathic Diarrhea: Results from a Phase 3 Clinical Trial,” is scheduled for June 3, 2024, at 2:00 PM CDT. Dr. Lisa Conte, Jaguar Health’s Chief Scientific Officer, added: “The presentation at ASCO underscores the importance of our research and the significant impact Mytesi® could have on the lives of patients dealing with chronic gastrointestinal conditions. We look forward to sharing these data with the oncology community and discussing the potential implications for broader clinical practice.” The successful completion of this Phase 3 trial paves the way for Jaguar Health to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) later this year. If approved, Mytesi® could become the first FDA-approved therapy specifically for chronic idiopathic diarrhea. About Jaguar Health, Inc. Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products. The company’s lead product, Mytesi® (crofelemer), is an FDA-approved anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. For more information, please visit www.jaguar.health. Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding the anticipated timing of regulatory submissions and potential regulatory approval of Mytesi® for additional indications. These statements are based
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