Shares of clinical-stage biopharmaceutical Cara Therapeutics, Inc. CARA surged after the company announced that its phase III trial on lead candidate Korsuva (difelikefalin) can continue as planned without any changes in enrollment, based on the recommendation of the Independent Data Monitoring Committee (IDMC).
Cara’s shares have gained 14.3% in the past twelve months, against the industry’s decline of 23.5%.
The phase III trial 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 achieving at least a 3-point improvement from baseline in the weekly mean of the daily 24-hour worst itching intensity Numeric Rating Scale (NRS) score at week 12.
Cara recently completed an interim statistical analysis of the trial, wherein the IDMC recommended that the trial will continue as planned with no changes to the original enrollment target of 350 patients. The IDMC’s recommendation was based on the results of a prespecified interim conditional power assessment, conducted after approximately 50 percent of the targeted patient number completed the designated 12-week treatment period.
The company plans to complete the study shortly and report top-line data in the first half of 2019.
Cara is focused on developing new chemical entities designed 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 as well as certain immune cells. The candidate demonstrated statistically significant reductions in phase II trials in itch intensity and improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus. The candidate also showed reduction in moderate-to-severe pain in a phase II/III trial in post-operative patients.
The successful development and commercialization of the candidate will be a significant boost 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, whereby it licensed worldwide rights to commercialize Korsuva injection for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in dialysis patients.
While there is huge potential for therapies for the treatment and management of 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 currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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