- Top-line data expected in early 3Q'15
SHELTON, Conn., June 23, 2015 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to selectively target peripheral kappa opioid receptors, today announced that it has completed enrollment in its Phase 2 proof-of-concept trial of its lead kappa opioid agonist, CR845, for the treatment of uremic pruritus (UP).
"We are pleased to have completed enrollment of our Phase 2 trial of I.V. CR845 in uremic pruritus and look forward to announcing top-line data early next quarter," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "UP is an area of high unmet need for dialysis patients and we believe that I.V. CR845 has the potential to significantly reduce their itch burden and improve overall quality of life."
UP is a chronic systemic itch condition that can occur in patients with renal failure and is often seen in patients receiving hemodialysis. There are more than 400,000 patients in the United States and 2.2 million globally undergoing hemodialysis. An estimated 50 percent of these patients suffer from renal or uremic pruritus. Currently, there are no approved products in the United States for the condition, which can often be severe and resistant to traditional itch treatments, such as corticosteroids and antihistamines.
The Phase 2 study is a double‐blind, randomized, placebo‐controlled trial designed to evaluate the efficacy of I.V. CR845 compared to placebo in reducing the intensity of itch in dialysis patients over a two-week dosing period. The primary endpoint of the study is the change from baseline of the average worst itching during the second week of treatment, as recorded on a visual analog scale. Secondary endpoints focus on quality of life measures associated with pruritus burden using a series of previously validated self-assessment scales. The study enrolled 65 dialysis patients at multiple sites in the U.S. A previously completed Phase 1 study of CR845 in 24 dialysis patients indicated that I.V. CR845 was safe and well-tolerated, and exhibited dose-linear pharmacokinetics across a five-fold dose range.
About CR845
CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus. In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in pain intensity and opioid-related side effects. In over 440 subjects dosed to date, I.V. CR845 was found to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists. Cara expects to initiate its Phase 3 Program of I.V. CR845 for acute pain with a first adaptive pivotal trial in laparoscopic abdominal surgery in 3Q'15. In addition, a Phase 2 trial of CR845 in osteoarthritis patients using an oral tablet formulation is planned for 3Q'15.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body's peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.
Forward-looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing for of the reporting of topline results of the Company's Phase 2 trial of I.V. CR845 in dialysis patients experiencing uremic pruritus and the potential for successful results of the trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics' filings with the Securities and Exchange Commission, including the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2014 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.