Jaguar Health provides update on Type C meeting with FDA

Jaguar Health (JAGX) provided a recap on the company’s assessment of the in-person Type C Meeting on May 28, 2025 with the Division of Gastroenterology of the U.S. Food and Drug Administration to discuss the statistically significant responder analysis results for adult patients with breast cancer in Napo’s recently conducted Phase 3 OnTarget trial. “We were very happy to take part in the face-to-face Type C Meeting, the catalyst for which was the positive data in the subpopulation of breast cancer patients from our OnTarget trial,” said Lisa Conte, CEO. “Napo proposed two simultaneous potential pathways during the meeting for making crofelemer available to metastatic breast cancer patients with the significant unmet medical need of CTD: conducting a pivotal treatment trial to facilitate approval of crofelemer for CTD in this focused patient population; and the prompt pursuit of authorization to initiate an expanded access program for breast cancer patients with CTD who may not be eligible for this study, including breast cancer patients in the adjuvant and neoadjuvant settings. We are pleased with the constructive and productive discussion that took place with the FDA during the meeting. Last week the FDA formally acknowledged both of these key discussion points in correspondence to Napo. We plan to submit a protocol to the FDA for a pivotal treatment trial for a smaller number of metastatic breast cancer patients using crofelemer.” Patient advocates participated in the Type C Meeting to share their raw and personal experience with CTD, including a metastatic breast cancer patient with uncontrollable diarrhea who received a prescription for crofelemer. “The design of the protocol for OnTarget was based on a survey of cancer patients. Today there are close to 100 approved targeted cancer agents. Thanks to these amazing drugs, metastatic cancer patients are living longer, frequently rendering cancer, and CTD, chronic ailments with which to live. To deepen our understanding of the current population of metastatic cancer breast with CTD, and ensure the clinical meaningfulness of the design of the anticipated pivotal treatment trial, we plan to conduct a new survey of this cancer patient population. Embracing a sharp strategic focus on orphan indications seems to fit with the new administration’s efforts and philosophy,” said Conte. “Dr. Marty Makary, the new Commissioner of the FDA, commented in April 2025 that the agency will open a new regulatory pathway based on what he called a ‘plausible mechanism,’ focusing mainly on rare or incurable diseases.” As expressed during the Type C Meeting, the data from the first-of-its-kind prophylactic OnTarget study is invaluable, providing new insights into the natural history of the important and debilitating side effect of CTD. Diarrhea is a common side effect of targeted cancer therapies and can lead to dose changes, treatment delays, and often cessation of lifesaving cancer therapy. The benefit to risk ratio of crofelemer is well-documented, as the active agent has been commercialized for the approved indication of HIV-related diarrhea since 2012, with no crofelemer-related reported serious adverse events.