Benzinga | Dec 10, 2021 08:02AM EST

Jaguar Health Highlights Presentation Of Findings From Investigator-Initiated Phase 2 HALT-D Study Of Crofelemer For Prevention Of Chemo-Induced Diarrhea In Breast Cancer Patients At San Antonio Breast Cancer Symposium

Results of the study provide the first proof-of-concept data for potential use of crofelemer - a novel, oral, plant-based, non-opioid antidiarrheal prescription medication - in breast cancer patients

SAN FRANCISCO, CA / ACCESSWIRE / December 10, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) and its wholly owned subsidiary Napo Pharmaceuticals today announced the third-party presentation of findings from the investigator-initiated HALT-D trial evaluating crofelemer for preventing chemotherapy-induced diarrhea (CID) in HER2-positive breast cancer patients being treated with trastuzumab, pertuzumab and a taxane. These therapies cause CID in up to 80% of breast cancer patients, reaching grade 3, which often requires hospitalization, in 8-12% of patients. No antidiarrheal medications are currently approved that specifically target the underlying mechanism of CID.

As presented today at SABCS by lead study investigator Paula Pohlmann, MD, PhD, formerly from Georgetown University and now Associate Professor, MD Anderson Cancer Center, HALT-D included 51 breast cancer patients scheduled to receive at least three cycles of chemotherapy and randomly assigned to either crofelemer in cycles 1 and 2 or the control group, which received standard of care. Antidiarrheal medications for breakthrough diarrhea were permitted but not given prophylactically. Findings showed that the primary endpoint, the incidence of diarrhea for at least two consecutive days, was not statistically different for the two groups. However, crofelemer patients demonstrated significantly better outcomes compared to control group patients across a number of key secondary endpoints in incidence and severity of diarrhea in cycle 2 based on Investigator and Patient Reported Outcomes (PRO) as previously reported in the study abstract (see Jaguar Health's November 19, 2021 press release). In the poster presented today, additional findings include that CID occurred significantly less (23%) in the crofelemer group during cycle 1 and crofelemer patients were 1.8 times more likely than control patients to have their diarrhea resolved.

"Our findings show benefits of crofelemer across a range of important diarrhea-related measures, including its incidence, severity and probability of resolving," said Dr. Pohlmann. "The lack of difference in the primary endpoint was due to about 70% of patients in both groups having at least two consecutive days of diarrhea, regardless of cycle or CID treatment group; in fact the typical cancer patient experiences many more days of CID. It is clear that the primary endpoint is not clinically relevant as it does not differentiate the severity nor duration of CID among treatment groups. We are pleased the secondary endpoints provide a more precise assessment of CID, which will guide future studies."

"These important HALT-D findings give us hope that the side effect of diarrhea that often accompanies these very effective chemotherapy regimens for HER2-positive breast cancer can be mitigated and make the treatment more tolerable," said Sandra M. Swain, MD, Associate Dean for Research Development at the Georgetown University Medical Center and the senior investigator of the study. "The findings support further testing of crofelemer in CID, and help identify appropriate endpoints that take into account its frequency and severity, which impacts patients' quality of life and dignity."

Napo Pharmaceuticals and Jaguar Health President and CEO Lisa Conte said, "With more than 44 presentations at SABCS reporting CID as a prevalent side effect in clinical studies that evaluated breast cancer therapies, there is a clear unmet need for prophylactic CID treatment. We are pleased with the HALT-D study results which show the potential benefit of crofelemer, and are also pleased that the results provide important proof of concept data for the potential use of crofelemer in breast cancer patients. We thank both the HALT-D investigators and the patients who participated in this study. Our ongoing phase 3 OnTarget study evaluating crofelemer as a prophylactic treatment for cancer therapy-related diarrhea demonstrates our continued commitment to comprehensive care of cancer patients."

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 is sponsored by Napo Pharmaceuticals, Jaguar Health's wholly owned subsidiary. For more information about the OnTarget trial visit clinicaltrials.gov (NCT04538625).