Jaguar Health Announces Topline Results of Investigator-Initiated Phase 2 Study of Crofelemer for Prevention of Chemotherapy-Induced Diarrhea (CID) in Breast Cancer Patients - Seite 2

"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.

More About HALT-D¹

The patients in the HALT-D trial were scheduled for at least three consecutive 21-day cycles of chemotherapy with THP (trastuzumab and pertuzumab with paclitaxel or docetaxel) or TCHP (docetaxel, carboplatin, trastuzumab and pertuzumab). Patients were randomized 1:1 to receive crofelemer during chemotherapy cycles 1 and 2, or standard-of-care with no prophylactic antidiarrheal therapy. All patients received breakthrough antidiarrheal medications as needed.

The primary endpoint was the incidence of any diarrhea (grades 1-4) for two or more consecutive days. Secondary endpoints included the incidence of any diarrhea and of severe diarrhea (grades 3 or 4), time to onset and duration of diarrhea, stool consistency, frequency of breakthrough antidiarrheal medication use, and quality-of-life measures. Data included physician assessments and patient-reported outcomes.

Full results for the secondary endpoints will be presented in the virtual and narrated poster available on the SABCS website and presented in person at the SABCS poster session from 7:00 am to 8:30 am CT on December 10. The full study results are expected to be submitted for publication in a medical journal. Jaguar Health plans to sponsor a closed satellite in-person/virtual event at SABCS on CID in breast cancer patients. The date and timing for the event will be provided in an upcoming announcement.