Cara Therapeutics Inc. (NASDAQ: CARA) shares made a solid gain on Wednesday after the biotech announced positive results from a midstage trial. The positive top-line data comes from the firm’s adaptive Phase 2/3 trial of IV CR845 in patients undergoing abdominal surgeries.
The primary endpoint was pain relief as measured over the first 24-hour period after the baseline dose (0 hour) post-surgery for all combined surgeries. In addition to safety, the secondary endpoints included incidence of vomiting, improvement in impact scores of post-operative nausea and vomiting, reduction in use of rescue analgesic medication, as well as patient global assessment at 24 hours post baseline dose after surgery.
At the 1.0 mcg/kg dose, IV CR845 demonstrated statistically significant reductions in pain intensity compared to the placebo at all pre-specified post-operative periods of 0 to 6 hours, 0 to 12 hours, 0 to 18 hours and 0 to 24 hours.
Additionally, IV CR845 treatment resulted in statistically significant reductions in the incidence of post-operative nausea and vomiting over the 24-hour period post-surgery for both 0.5 and 1.0 mcg/kg doses.
Derek Chalmers, Ph.D., D.Sc., president and CEO of Cara, commented:
We are very pleased that these data demonstrate the overall benefit of I.V. CR845 in both providing pain relief across surgery types up to 24 hours post-surgery and reducing post-operative nausea and vomiting, a significant medical need in the post-operative setting. As there continues to be a critical need for new post-surgical analgesics like I.V. CR845 that lack abuse potential and traditional mu opioid side effects, we will be assessing all options, including discussions with regulators, as to how to best move this program forward.
Shares of Cara were last seen up about 14% at $18.77, with a 52-week trading range of $11.11 to $28.05.