Clinical Data The Study randomized 24 healthy Beagle dogs into three parallel groups over a treatment period of 28-days dosed with the TKI and placebo or crofelemer (crofelemer 125 mg delayed-release tablets) up to four times a day. Specifically, one group of dogs received crofelemer twice daily (BID group) with the TKI; another group received crofelemer four times daily (QID group) with the TKI; and the third group received placebo capsules four times a day (placebo group) with the TKI.


Top line results show that dogs enrolled in the QID group were 26.8 times more likely to be a “responder” than dogs in the placebo group (p=0.02). Specifically, 7/8 of the dogs in the QID group were “responders” compared to 3/8 of the dogs in the placebo group. Furthermore, dogs randomized to the BID group were 17.8 times more likely to be a “responder” when compared to dogs randomized to the control group (p=0.03). Specifically, 6/8 dogs in the BID group were “responders” compared to 3/8 dogs in the placebo group. There was no significant difference between dosing crofelemer twice daily compared to four times daily in providing symptomatic relief from diarrhea in the dogs. As stated above, the combined BID and QID groups demonstrated superior benefit for “responders” (p= 0.01).

An additional endpoint evaluated the total number of watery stools during the study between the placebo and the two crofelemer treatment groups in the study. This analysis showed that dogs receiving placebo had approximately 33% higher incidence of watery stools when compared to the dogs randomized to the crofelemer BID or QID groups (p=0.04).