- Two-part study to evaluate safety, pharmacokinetics and anti-itch effects in hemodialysis patients
- Top-line data expected in 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
There are no currently approved therapeutics in
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.
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.
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
CONTACT: CORPORATE CONTACT:Source:
Derek Chalmers, Ph.D., D.Sc. President & CEO Cara Therapeutics, Inc.203-567-1500 MEDIA CONTACT: Annie Starr6 Degrees 973-415-8838 email@example.com INVESTOR CONTACT: Jesse BaumgartnerStern Investor Relations, Inc. 212-362-1200 Jesse@sternir.com
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