Cara Therapeutics (CARA 18.91, +2.47, +15.05%) is trading sharply higher today after reporting positive top-line clinical data.
Cara Therapeutics is a clinical-stage biopharma focused on commercializing new chemical entities designed to alleviate pruritus and pain by selectively targeting kappa opioid receptors (KORs). The company is developing a proprietary class of product candidates, led by KORSUVA (CR845/difelikefalin), that target the body's peripheral nervous system and certain immune cells. The FDA has conditionally accepted KORSUVA as the trade name for CR845/difelikefalin injection, an investigational drug product for the treatment of itch, whose safety and efficacy have not been fully evaluated by any regulatory authority.
In Phase 2 trials, KORSUVA has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-severe chronic kidney disease-associated pruritus, or CKD-aP, and is currently being investigated in Phase 3 trials in hemodialysis patients with CKD-aP. In addition, CR845/difelikefalin has also demonstrated initial signs of efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics. Cara has no products currently available for sale, and substantially all of its revenue to date has come from license agreements.
Cara notes that there are over 20 million patients with chronic pruritus (itching) treated with prescription drugs in the US each year. Many of these patients still experience inadequate relief of their itching. Pruritus or itching can be caused by a number of diseases ranging from dermatological conditions (atopic dermatitis, eczema, and psoriasis) to hepatic conditions (hepatitis, primary biliary cirrhosis) to chronic kidney disease. In fact, most of the dermatological patients diagnosed with atopic dermatitis or psoriasis suffer from itching as well as a third of the patients suffering from cholestatic liver disease and chronic kidney disease.
The current therapies, primarily corticosteroids and antihistamines, are many times ineffective in treating the disease and/or produce significant side effects. Because of this, there is a large opportunity for a novel product that is effective in managing pruritus while minimizing side effects.
Turning to today's news, Cara announced positive top-line data from the adaptive Phase 2/3 trial of I.V. CR845 in patients undergoing abdominal surgeries. At the 1.0 mcg/kg dose, I.V. CR845 demonstrated statistically significant reductions in pain intensity compared to placebo at all pre-specified post-operative periods.
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. Cara will be assessing all options, including discussions with regulators, as to how to best move this program forward. The current practice of perioperative pain management anchored around traditional opioids often results in frequent opioid-related adverse events, such as nausea and vomiting, which can be debilitating and delay patients' post-surgical recovery. The ability of I.V. CR845 to provide not only additional pain relief but also a considerable decrease in the incidence and degree of post-operative nausea and vomiting underscores the potential of I.V. CR845 to provide meaningful clinical benefit in the immediate post-operative recovery period.
In sum, the stock has been trading in a narrow range over the past year or so in the $12-16 range. Today's news has caused the stock to break above that range on strong volume. Overall, this is clearly a positive development for Cara, and investors seem quite pleased with the new top-line data.
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