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$CARA Announces Successful Completion of Phase 1b Trial

Cara Therapeutics Reports Positive Top-Line Data From Phase 1b Trial of I.V. CR845 in Dialysis Patients

  • I.V. CR845 observed to be safe, well tolerated, and to exhibit dose linear exposure in patients undergoing dialysis
  • Effective itch reduction seen in subgroup of patients with uremic pruritus
  • Phase 2 trial in dialysis patients with uremic pruritus underway

SHELTON, Conn., Dec. 17, 2014 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to selectively target peripheral kappa opioid receptors, today announced the successful completion of a Phase 1b trial of an intravenous (I.V.) formulation of CR845 in dialysis patients. In the repeat dosing of I.V. CR845 over one week was observed to be safe and well-tolerated across a five-fold dose range, and the trial established a dosing regimen for the ongoing Phase 2 trial in dialysis patients with uremic pruritus. The company expects to report top-line data from this trial in the first half of 2015.

“The completion of this Phase 1b trial and initiation of the Phase 2 study in uremic pruritus is an important step in establishing the potential clinical utility of CR845 in this area of significant unmet medical need,” said Frederique Menzaghi, Ph.D., Vice President of Research and Development at Cara Therapeutics. “We are particularly encouraged that preliminary data from this trial indicate that CR845 effectively reduced “worst itching” scores in those subjects who entered the study with ongoing moderate-to-severe uremic pruritus. We look forward to reporting top-line data from our Phase 2 trial in the first half of 2015.”

There are currently no 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 1b trial was a double-blind, randomized, placebo-controlled trial designed to evaluate the safety and pharmacokinetics (PK) of I.V. CR845 in 24 hemodialysis patients. I.V. CR845 was administered as a bolus dose (0.5 ug-2.5ug/kg) after each dialysis session up to three times a week (t.i.w.). Pharmacokinetic analysis indicated that I.V. CR845 exhibited dose linear increases in Cmax and AUC with an approximate 10-fold increase in AUC across doses in these dialysis patients compared to normal subjects.

I.V. CR845 was observed to be safe and well tolerated over the one-week dosing period with no serious adverse events (AEs) reported. The most common AEs were transient facial tingling and headache. Although uremic pruritus was not an inclusion criterion for randomization, three subjects entered the trial with “worst itching” baseline scores in the moderate-to-severe range, >4.0 on a 10.0 point visual analog scale (VAS). All three subjects received t.i.w. dosing of I.V. CR845 (two subjects at 1ug/kg, one at 2.5ug/kg) and ended the one-week dosing period with reported “worst itching” scores of 1.0 or less.

“We are very encouraged that our clinical data to date in hemodialysis patients indicate that CR845 may provide a novel therapeutic approach for patients suffering the burden of chronic pruritus associated with chronic kidney disease,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “The ability to broaden the potential clinical utility of CR845 beyond pain into the spectrum of conditions associated with chronic pruritus is a significant opportunity, and we look forward to seeing the data from this additional set of patients with uremic pruritus next year.”

The ongoing Phase 2 trial will measure the efficacy of I.V. CR845 compared to placebo in reducing the intensity of itch in dialysis patients with baseline “worst itching” scores of 4.0 or greater over a two-week dosing period. The primary endpoint of the study will be the change from baseline in the average “worst itching” scores during the second week of treatment, as recorded on a VAS. 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 a total of 60 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 uremic 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 400 subjects dosed to date, I.V. CR845 was observed 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. In a human abuse liability trial, I.V. CR845 met the primary endpoint showing highly statistically significant reductions (p < 0.0001) in scores for “drug liking,” as well as “feeling high,” “overall liking,” and “take drug again” when compared to I.V. pentazocine, a Schedule IV opioid analgesic.

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 reporting results of the Company’s Phase 2 trial of I.V. CR845 in dialysis patients experiencing uremic pruritus, the expected level of patient enrollment 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.

Derek Chalmers, Ph.D., D.Sc.
President & CEO
Cara Therapeutics, Inc.
Annie Starr
6 Degrees
Jesse Baumgartner
Stern Investor Relations, Inc.

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