Cara Therapeutics, Inc. (CARA), a biopharmaceutical company focused on manufacturing and commercialization of several chemical entities developed to provide relief from pruritus by precisely targeting peripheral kappa opioid receptors, announced results about its KARE Phase 2 dose-ranging clinical trial of Oral KORSUVA™. The clinical trial isused to treatmild to severe cases of pruritus. 401 patients were enrolled for the trial at multiple clinical sites across the United States. CARA stock plummeted immensely adjacent to the news.
Cara Therapeutics Inc. (CARA) shares were falling -43.62% to trade at $15.5 in current market trading at last check. CARA stock closed the last session at $25.79, decreasing -1.19% or -$0.31. Shares of the company fluctuated between $25.3874 and $26.10 throughout the day. In the past 12 months, the company’s stock has advanced 65.53%, and in the last week, the stock has moved down -7.86%
About KARE Phase 2 Trial
The KARE Phase 2 trial studies the anti-itch effects of KORSUVA in patients effected with atopic dermatitis, a highly inflammatory skin disease. The phase 2 trial consists of a randomized, double-blind, placebo-controlled evaluation designed to study the efficacy and safety of Oral KORSUVA for patients consisting of mild to extreme symptoms of pruritus in 401 adult subjects with atopic dermatitis.
Patients were categorized in accordance to the severity of the disease. 64% of the patients were segmented as having mild symptoms, while 36% fell into the moderate-severe category. Each patient was randomized to three tablets with varied dosages of Oral KORSUVA including 0.25 mg, 0.5 mg, and 1 mg taken twice every day in comparison to a placebo for 12 weeks followed by 4 weeks of an active extension phase.
No dose primarily met the endpoint, however immense improvement was seen for the 1mg dose group which remained sustained through 75% of the treatment period. A statistical improvement was also seen from the 0.5mg dosage compared to the placebo.
Oral KORSUVA was generally well tolerated in the patients, however abdominal pain, nausea dry mouth, headache, dizziness, and hypertension were reported in a small percentage of the subjects as well.
AD is a chronic, pruritic inflammatory dermatosis and can be aggravated with excessive scratching. It greatly impairs the quality of life and can cause interrupted sleep and psychological disturbance. Available immunosuppressants in the market have shown to reduce pruritus, however, safety concerns, as well as limited efficacy, have remained a halting factor.
CARA operates in the remunerative field of biopharmaceuticals and has remained consistent in their clinical trials. However, safety concerns combined with low efficacy has not shown a positive result with CARA stock plummeting immensely.