Cara Shares Up on Positive Phase III Data for Itchiness Drug

Shares of Cara Therapeutics, Inc. CARA increased about 20% after the company announced positive top-line data from the KALM-1 pivotal phase III study of Korsuva (CR845/difelikefalin) injection in hemodialysis patients with moderate-to-severe chronic kidney disease-related pruritus (CKD-aP). Cara’s shares have rallied 38.8% year to date compared with the industry’s growth of 0.1%.

Itchiness is a common issue among patients on dialysis. The study showed that dialysis patients experiencing itchiness, who were given Korsuva injection, showed statistically significant improvement compared with those on placebo.

The phase III study KALM-1 is a multicenter, randomized, double-blind, placebo-controlled 12-week treatment trial (with a 52-week open label extension phase) that is designed to evaluate the safety and efficacy of 0.5 mcg/kg Korsuva injection in 350 hemodialysis patients with moderate-to-severe pruritus. The primary efficacy endpoint is the proportion of patients on 0.5 mcg/kg of Korsuva Injection achieving at least a three-point improvement from baseline in the weekly mean of the daily 24-hour worst itching intensity Numeric Rating Scale (NRS) score at week 12. Korsuva showed a three-point or greater improvement in itchiness after 12 weeks in 51% of patients, while only 28% showed improvement on placebo, per the company. Further, 39% percent of patients on the drug were able to show a four-point or greater improvement in itchiness compared with 18% of patients on placebo.

Korsuva injection resulted in statistically significant separation from placebo after only one week of treatment and a sustained significant benefit through 12 weeks.

Cara is focused on developing new chemical entities to alleviate pruritus and pain by selectively targeting peripheral kappa opioid receptors (KORs). Korsuva is a first in class KOR agonist that targets the body's peripheral nervous system and certain immune cells. The successful development and commercialization of the candidate will significantly boost growth for the company. The FDA has conditionally accepted Korsuva as the trade name for difelikefalin injection.

The company had earlier inked a licensing deal with Vifor Fresenius Medical Care Renal Pharma Ltd., a joint company formed by Vifor Pharma Group and Fresenius Medical Care FMS. Per the deal, Cara licensed worldwide rights except in the United States, Japan and South Korea to commercialize Korsuva injection for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in dialysis patients to Vifor Fresenius Medical Care Renal Pharma Ltd  (VFMCRP). Per the agreement, Cara will commercialize Korsuva injection in the United States & co-promote with VFMCRP in United States.

While there is huge potential for therapies to treat and manage postoperative acute pain, moderate-to-severe chronic pain and neuropathic pain, the competition is stiff from the likes of existing players like Mallinckrodt MNK and Pacira Pharmaceuticals PCRX, among others.

Cara Therapeutics, Inc. Price