Benzinga | Nov 19, 2021 09:23AM EST

Jaguar Health Announces Topline Results Of Investigator-Initiated Phase 2 Study Of Crofelemer

Jaguar Health, Inc. (NASDAQ:JAGX) today announced topline results of the third-party, investigator-initiated Phase 2 HALT-D trial evaluating crofelemer for the prevention of chemotherapy-induced diarrhea (CID) in HER2-positive breast cancer patients being treated with trastuzumab, pertuzumab and a taxane.1 These therapies are known to cause CID in up to 80% of breast cancer patients, reaching grade 3 (requiring hospitalization) in 8-12% of patients.2-5 CID can have a negative impact on quality of life, particularly when it persists through much of the course of chemotherapy, and may result in stopping cancer treatment. There are no medications currently approved for CID. Jaguar Health believes crofelemer is the only antidiarrheal medication under clinical investigation that specifically targets the underlying mechanism of CID.

As reported in the abstract (Publication Number: P5-18-09) posted by the San Antonio Breast Cancer Symposium (SABCS), the study included 51 breast cancer patients randomly assigned to either crofelemer or control standard of care with no prophylactic antidiarrheal medications. Findings showed that the primary endpoint - the incidence of having diarrhea for two or more days - was not statistically different for the two groups since about 70% of patients had this outcome regardless of cycle or CID treatment group, which is consistent with the experience of CID in patients receiving these chemotherapy regimens. The crofelemer group demonstrated better outcomes compared to the control group for a number of key secondary endpoints:1

* Lower incidence of grade 2 or higher-grade diarrhea for the crofelemer group compared to the control group during cycle 2, based on patient-reported outcomes: 9.0% vs. 33.3%.

* Lower incidence of grade 2 or higher-grade diarrhea for the crofelemer group compared to the control group during cycle 2, based on investigator assessments: 9.5% vs. 41.1%.

* No patients in the crofelemer group experienced grade 3 or grade 4 diarrhea during cycle 2 compared to 17.6% of patients in the control group, based on patient-reported outcomes.

"A number of findings of secondary endpoints were significantly in favor of crofelemer," said lead study investigator Paula Pohlmann, MD, PhD, formerly from Georgetown University and now Associate Professor, MD Anderson Cancer Center. "These positive HALT-D data not only support further testing of crofelemer in CID, they also provide evidence for the selection of more appropriate endpoints to assess improvements in CID, which take into account both the frequency and severity of diarrhea."

"These are important findings for patients with CID and the physicians who treat them," said Sandra M. Swain, MD, Associate Dean for Research Development at the Georgetown University Medical Center and the senior investigator of the study. "The data from this HALT-D trial gives us hope that the side effect of diarrhea seen with very effective chemotherapy for HER2-positive breast cancer can be diminished and make the treatment more tolerable for patients."

Jaguar Health President and CEO Lisa Conte said, "We are pleased by the findings of the HALT-D study. A major challenge in studying CID is the lack of consensus on how to measure it. Not only did the HALT-D study show the potential benefit of crofelemer for this indication, we believe it supports the endpoints we selected for our ongoing pivotal Phase 3 OnTarget trial. We want to thank the investigators for their important work on this study and we look forward to continuing to advance the development of crofelemer to potentially address the serious consequences of CID on both a cancer patient's dignity and their ability to continue their cancer treatment."

The HALT-D study is separate from the OnTarget study, the pivotal Phase 3 clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. OnTarget was initiated in October 2020 by Napo Pharmaceuticals, Jaguar Health's wholly owned subsidiary.