Cara Therapeutics Completes Planned Enrollment of Eight-Week Multi-Dose Phase of Adaptive Trial of I.V. CR845 in Chronic Kidn...
November 29 2016 - 8:00AM
- 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 -
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
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