Jaguar Health to explore approval pathway for crofelemer based on Phase 3 result

In a shareholder letter, the company said in part, “Jaguar will be hosting a webcast, providing a review of earnings for the second quarter of 2024, at 8:30 a.m. Eastern on Tuesday, August 13, 2024. We will also further review the data and regulatory strategy for the clinically meaningful results we reported July 23, 2024 – identified in patients with breast and respiratory cancer, including lung cancer – in the initial data from our recently completed phase 3 OnTarget trial of crofelemer. OnTarget broadly and boldly studied the prophylaxis of diarrhea in adult cancer patients with 10 distinct types of solid tumors receiving targeted therapy, with or without standard chemotherapy; yet the meaningful clinical signals are in breast and lung cancer patients, two of the three most common cancer diagnoses. We are collaborating with our clinical and scientific advisers to evaluate the significance of these clinical outcome signals in order to prepare for scientific publication submission and FDA meetings, as we plan to explore the pathway of approval to make crofelemer, our novel, oral plant-based prescription medicine, available to breast and lung cancer patients for cancer therapy-related diarrhea.”