Cara Therapeutics Inc (NASDAQ:CARA) posted topline results of Oral Korsuva in a double-blind, randomized, and placebo-controlled clinical study designed to treat Atopic Dermatitis patients with mild to severe pruritus.
The Phase 2 clinical study is conducted on 401 patients at multiple sites across the US. CMO of Cara Therapeutics, Joana Goncalves said the company is excited to satisfy the 4-point responder analysis for phase 3 registration in the AD group with mild to moderate pruritus. He further said the company identified the dosage requirement of Oral Korsuva and defined the patient group to discuss the Phase 3 registration program with the US FDA soon.
Promising anti-itch effects
Co-Director at the Center for the Study of Itch and Sensory Disorders in Washington, Brian Kim, said the KARE phase 2 clinical studies showed distinct anti-itch effects in atopic patients when treated using Oral Korsuva. It is a promising and innovative formulation to address the main symptom of AD in patients with mild to moderate pruritus.
In the clinical trial, the patients have well-tolerated various doses of oral Korsuva. However, it failed to satisfy the primary endpoint in Phase 2 dose-ranging clinical study in AD patients administered with 0.5 mg, 0.25 mg, and 1 mg of Oral Korsuva against placebo.
Cara Therapeutics enhanced the sample size for 0.5 mg dose as per the recommendation of IDMC (Independent Data Monitoring Committee). Despite this, it could not achieve a primary efficacy endpoint.
Around 2% to 5% of adults and 25% of children suffer from pruritus and chronic inflammatory disease – AD. It gets aggravated with continuous itching. Pruritus affects the quality of life of patients with AD.
Factors responsible for atopic dermatitis
Various factors like environmental triggers, impaired skin barrier, genetic predisposition, and immune dysregulation are responsible for atopic dermatitis. Systemic immunosuppressants play an essential role in mitigating pruritus. But, their use is limited because of safety concerns for long-term use and reserved for patients with moderate to severe atopic dermatitis.
On April 14, 2021, the CEO of Cara Therapeutics, Derek Chalmers, will take part in the 20th ANHC (Annual Needham Healthcare Conference). The investors can access the presentation from its website under Events & Presentations.
Cara Therapeutics will join the S&P SmallCap 600 on April 8, 2021, by replacing MTS Systems Corp.