- Two-part study to evaluate safety, pharmacokinetics and anti-itch effects in hemodialysis patients
- Top-line data expected in first half of 2015
SHELTON, Conn., Aug. 6, 2014 (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 the dosing of the first dialysis patients in a Phase II trial of an intravenous formulation of its peripherally-selective kappa opioid agonist, CR845, for the treatment of uremic pruritus. The company expects to report top-line data from this trial in the first half of 2015.
"The initiation of this uremic pruritus study is an important step in establishing the potential clinical utility of CR845 in this area of significant unmet medical need," said Frédérique Menzaghi, Ph.D., Vice President of Research and Development at Cara Therapeutics. "Preclinical studies with CR845 across a range of pruritus models, as well as clinical data with other kappa agonists, indicate that CR845 may provide a novel therapeutic approach for patients suffering the burden of chronic pruritus associated with chronic kidney disease, as well as a wide spectrum of other clinical conditions."
There are no currently approved therapeutics in the United States for uremic pruritus, an intractable type of itch that is generally resistant to conventional treatments, and diminishes the quality of life for almost half of all kidney dialysis patients.
The Phase II study is a double‐blind, randomized, placebo‐controlled trial designed to evaluate the safety and pharmacokinetics (PK) of intravenous CR845 in hemodialysis patients, and its efficacy in hemodialysis patients experiencing uremic pruritus. The study will be conducted in two parts: In Part A, the pharmacokinetic and safety profile of repeat doses of I.V. CR845 will be assessed in hemodialysis patients over a one week period; Part B will measure the efficacy of 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 will be the change from baseline of the average worst itching during the second week of treatment, as recorded on a visual analog scale. Secondary endpoints will focus on quality of life measures associated with pruritus burden using a series of previously validated self-assessment scales. The study will enroll 84 dialysis patients at multiple sites in the U.S.
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 II 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 400 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. A previously completed Phase I study in end-stage kidney disease patients has established that CR845 is safe and generally well tolerated in this population.
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 the Company's Phase II trial of IV CR845 in dialysis patients experiencing uremic pruritus, the design and the potential for successful results of the trial, the timing of the reporting of the topline results of the trial, as well as the potential future regulatory and development milestones for the Company's product candidates. 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, 2013 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.