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Jaguar Health Announces the Presentation of Findings from the Investigator-Initiated Phase 2 HALT-D Study of Crofelemer for Prevention of Chemotherapy-Induced Diarrhea (CID) in Breast Cancer Patients at San Antonio Breast Cancer Symposium (SABCS 2021)
Results of the study provide the first proof-of-concept data for potential use of crofelemer - a novel, oral, plant-based, non-opioid antidiarrheal
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[{"type":"text","content":"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 patientsSAN 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 pat...