=Cara Therapeutics (CARA) announces top-line results from phase 2B trial

Cara Therapeutics announces top-line results from a Phase 2b trial of an oral tablet formulation of CR845 in patients with osteoarthritis of the knee or hip; Statistically significant 39 percent reduction in mean joint pain score in hip patients at eight weeks with 5.0 mg dose :

• Patients with OA of the hip maintained on the 5.0 mg dose to the end of the eight-week treatment period exhibited a statistically significant 39 percent reduction in mean joint pain score (p=0.043 vs. placebo); all patients (OA of the knee or hip) maintained on the 5.0 mg dose to the end of the eight-week treatment period exhibited a 35 percent reduction in mean joint pain score (p=0.111 vs. placebo).
• Patients maintained on the 1.0 mg and 2.5 mg tablet strengths did not exhibit significant reductions in mean joint pain scores compared to placebo.
• For patients maintained on the 5.0 mg dose, there was a statistically significant increase in the proportion of patients whose OA was "very much improved" or "much improved" as indicated by Patient Global Assessment score in both the total patient group (p <0.005 vs. placebo) and in patients with primary OA of the hip (p<0.006 vs. placebo).
• The reduction in pain score in the 5.0 mg dose group in hip patients was accompanied by a reduction in mean rescue medication of 41 percent at week eight versus placebo.
• An overall improvement of 62 percent from baseline in WOMAC scores was observed over the eight-week treatment period for the 5.0 mg dose group in hip patients.
• All tablet strengths were generally well tolerated with no drug-related serious adverse events (SAEs). For the 5.0 mg dose, the most common adverse events reported at the >5 percent incidence level were dry mouth (six percent) and constipation (12 percent). Importantly, there were no clinically significant changes in serum sodium levels observed during the eight-week treatment period for any dose group.

"We believe that the present trial of oral CR845 has highlighted the potential of a peripherally acting kappa agonist to provide clinical benefit in a chronic pain population and we're pleased that statistical significance was achieved for the 5.0 mg dose in patients with OA of the hip"