Jaguar Health to Announce Phase 3 Crofelemer Trial Results by July 23, 2024

Jaguar Health, Inc. (NASDAQ:JAGX), based in San Francisco, CA, has announced plans to host an investor webcast on or before July 23, 2024. This webcast aims to present the results of the company's pivotal phase 3 OnTarget trial, which investigates the use of crofelemer for preventing diarrhea in adult cancer patients with solid tumors undergoing targeted therapy with or without standard chemotherapy. The webcast will also provide updates on Jaguar's cancer supportive care portfolio, featuring contributions from the company's scientific team, patient advocates, and renowned oncology experts discussing cancer therapy-related diarrhea (CTD) and oral mucositis.

CEO Lisa Conte emphasized the importance of patients in Jaguar’s mission, highlighting that the OnTarget trial's comprehensive protocol was designed to accommodate the diverse treatment requirements of patients with solid tumors and targeted therapies. She expressed anticipation for sharing the trial results, noting that the complexity of the study necessitated the involvement of a specialized biostatistics and programming expert to manage the trial's intricate statistical needs. The third-party vendors tasked with analyzing the patient data have outlined the critical steps needed to ensure the results can be shared by the end of July.

Stacey Tinianov, a cancer survivor and founder of Advocates for Collaborative Education, underscored the significance of supportive care in maintaining patients' quality of life during cancer treatment. She pointed out that no side effect should be deemed "acceptable" or "tolerable," stressing the importance of addressing all adverse effects, including extreme fatigue, severe diarrhea, mouth sores, and chronic pain.

During the upcoming webcast, Jaguar will also discuss several advancements in their cancer supportive care portfolio:

1. In April 2024, Jaguar secured an exclusive 5-year U.S. in-license agreement for Gelclair®, an FDA-approved product for oral mucositis. Jaguar began promoting Gelclair at the Oncology Nursing Society Congress and the American Society of Clinical Oncology Annual Meeting.

2. In March 2024, Jaguar entered a binding term sheet with Turkish pharmaceutical company GEN for the commercialization of crofelemer in Turkey and eight neighboring countries, pending regulatory approval for specified indications, including CTD.

3. Jaguar has supported the "Make Cancer Less Shitty" advocacy program at various events, including the San Antonio Breast Cancer Symposium and the Oncology Nursing Society Congress. This program aims to empower cancer survivors to voice their opposition to debilitating treatment side effects.

4. A study published in January 2024 in PLOS ONE showed significant results for crofelemer in preventing CTD in dogs. The FDA conditionally approved Canalevia®-CA1 for treating chemotherapy-induced diarrhea in dogs in December 2021.

Crofelemer is distinguished as the only oral prescription drug approved under FDA botanical guidance. Extracted from the Croton lechleri tree in the Amazon rainforest, it is produced through a sustainable and fair trade harvesting program by Napo Pharmaceuticals, a Jaguar family company. The OnTarget study is assessing whether crofelemer can prevent or significantly reduce diarrhea when patients begin treatment with any of the 23 targeted therapies known to cause diarrhea in at least 50% of patients.

Cancer therapy-related diarrhea (CTD) is a prevalent side effect, with up to 95% of patients on tyrosine kinase inhibitors experiencing diarrhea. This condition can lead to a 40% higher likelihood of patients discontinuing their therapy. Additionally, oral mucositis is a painful and debilitating side effect affecting up to 40% of chemotherapy patients and as many as 90% of those undergoing treatment for head and neck cancers. Oral mucositis can lead to hospitalization, impaired quality of life, and increased healthcare costs due to its severe symptoms, which include difficulty eating or talking and a heightened risk of infection.

Jaguar Health's commitment to addressing these side effects reflects their broader mission of developing novel, plant-derived prescription medicines. With an emphasis on sustainable and ethical practices, Jaguar and its subsidiaries, including Napo Pharmaceuticals and Napo Therapeutics, are dedicated to providing essential supportive care and managing gastrointestinal symptoms across various complex disease states.