- Part A of the trial will evaluate three doses of I.V. CR845 versus placebo in 160 dialysis
patients -
- Top-line data expected in first quarter of 2017 -
STAMFORD, Conn., Nov. 29, 2016 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology
company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively
targeting peripheral kappa opioid receptors, today announced that it has completed patient enrollment for the multi-dose phase of
its adaptive Phase 2/3 trial of I.V. CR845 in dialysis patients suffering from moderate-to-severe uremic pruritus (UP). UP is an
intractable systemic itch condition in patients with chronic kidney disease (CKD), for which there are no approved therapies in the
United States.
“We’re very pleased to have completed enrollment as planned for Part A of the Phase 2/3 trial in pruritus
associated with chronic kidney disease, as these eight-week data will determine the optimal dosing to carry forward into planned
registration trials. In our previous Phase 2 trial, I.V. CR845 significantly reduced itch and improved the quality of life for
dialysis patients with this condition over a two-week treatment period,” said Derek Chalmers, Ph.D., D.Sc., President and Chief
Executive Officer of Cara Therapeutics. “We look forward to reporting top-line data from Part A of this trial in the first quarter
of 2017 and, based on the results, initiating the planned registration phase later in the year.”
About the Phase 2/3 Adaptive Trial
The Phase 2/3 trial is being conducted in a two-part adaptive design:
- Part A is a randomized, double-blind, placebo-controlled trial of three doses of I.V. CR845 (0.5 mcg/kg, 1.0 mcg/kg, and 1.5
mcg/kg) administered three times per week after dialysis over an eight-week treatment period in 160 patients.
- Part B will be a randomized, double-blind, placebo-controlled trial of one optimized dose of I.V. CR845 administered three
times per week after dialysis over a 12-week treatment period in up to 240 patients.
Primary and secondary endpoints will include itch intensity and quality of life measures associated with
pruritus burden, using a series of previously validated self-assessment scales.
About the Prior Phase 2 Trial of I.V. CR845 in Uremic Pruritus
The previously conducted Phase 2 trial was a double-blind, randomized, placebo-controlled trial designed to
evaluate the efficacy of I.V. CR845 (1.0 mcg/kg) compared to placebo in reducing the intensity of itch in dialysis patients over a
two-week dosing period. The trial enrolled 65 dialysis patients at multiple sites in the U.S.
The primary endpoint of the Phase 2 trial was the change from baseline of the average worst itching during the
second week of treatment, as recorded on a visual analog scale (VAS). Patients receiving I.V. CR845 experienced a 54 percent
greater reduction in worst itch scores than those receiving placebo (p-value = 0.016), with an average reduction of -48 percent
from baseline as measured by the VAS. I.V. CR845-treated patients also exhibited statistically significant reductions in both
daytime (-51 percent, p=0.03) and nighttime (-75 percent, p=0.007) worst itch scores compared to placebo treatment.
Secondary endpoints focused on quality of life measures associated with pruritus using a series of previously
validated self-assessment scales, including the Skindex 10 score. Patients receiving I.V. CR845 experienced a 71 percent greater
reduction in the average total Skindex 10 score at the end of the two-week treatment period than those receiving placebo (p-value =
0.031). Another secondary measure, itch-related sleep disturbances based on the Itch MOS Sleep Problems Index II, showed a positive
trend in patients receiving I.V. CR845, with a 62 percent improvement compared to placebo.
About Uremic Pruritus
Uremic pruritus (UP) is an intractable systemic itch condition that occurs with the greatest frequency and
intensity in chronic kidney disease (CKD) patients under hemodialysis (HD) and peritoneal dialysis; however, pruritus has also been
reported in CKD patients who are not yet on dialysis. Aggregate, longitudinal, multi-country studies calculate the weighted
prevalence of UP to be approximately 40 percent of patients with end-stage renal disease (ESRD), with approximately 24 percent of
patients reporting severe pruritus. Similarly, the majority of dialysis patients (approximately 60 percent) report pruritus, with
30 to 40 percent reporting moderate or severe pruritus. Recent data from the ITCH National Registry Study showed that among those
with pruritus, 59 percent had experienced symptoms daily or nearly daily for more than a year. Given its association with CKD/ESRD,
most afflicted patients will continue to have symptoms for months or years with currently employed anti-pruritic treatments, such
as anti-histamines and corticosteroids, unable to provide consistent adequate relief. Moderate-to-severe chronic pruritus has
repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life (such as poor sleep
quality), and is associated with depression. UP is also an independent predictor of mortality among HD patients, mainly related to
increased risk of inflammation and infections.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new
chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral 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 initial 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 of the reporting results of the trial, the expected timing of the
initiation of Part B of the trial for I.V. CR845 for UP, the ability of the trial to demonstrate an extended patient benefit, and
the potential for I.V. CR845 to be a therapeutic option for UP. 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, 2015 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.
MEDIA CONTACT: Annie Starr 6 Degrees 973-415-8838 astarr@6degreespr.com INVESTOR CONTACT: Michael Schaffzin Stern Investor Relations, Inc. 212-362-1200 michael@sternir.com
