Jaguar Health Inc JAGX announced the topline results of the investigator-initiated Phase 2 HALT-D trial evaluating crofelemer to prevent chemotherapy-induced diarrhea (CID). The trial included HER2-positive breast cancer patients being treated with trastuzumab, pertuzumab, and a taxane.
- 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 the cycle or CID treatment group.
- The crofelemer group demonstrated better outcomes compared to the control group for several key secondary endpoints.
- A lower incidence of grade 2 or higher-grade diarrhea for the crofelemer group was seen than the control group during cycle 2 based on patient outcomes and investigator assessments - (9.0% vs. 33.3%) and (9.5% vs. 41.1%), respectively.
- Based on patient-reported outcomes, 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.
- Price Action: JAGX shares are up 3.10% at $1.50 during the market session on the last check Friday.
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