Met primary endpoint with 68% reduction in worst
itching scores versus placebo after eight-week treatment period
(p<0.0019)
Met secondary endpoint in quality
of life domains versus placebo after eight-week treatment
period (p<0.0007)
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company
focused on developing and commercializing new chemical entities
designed to alleviate pain and pruritus by selectively targeting
peripheral kappa opioid receptors, today announced positive
top-line results from Part A of its Phase 2/3 trial showing that
I.V. CR845 met both primary and secondary endpoints for efficacy
(reduced itching and improved quality of life, respectively) in
patients with uremic pruritus (UP) with statistical significance.
UP is an intractable and debilitating systemic itch condition with
a high prevalence in patients with chronic kidney disease (CKD),
for which there are no approved therapies in the United States.
“We are extremely pleased with these results,
where I.V. CR845 demonstrated sustained clinical and quality of
life benefits in dialysis patients suffering from UP and supports
the viability of this therapeutic approach for the long-term
treatment of this unmet medical need,” said Derek Chalmers, Ph.D.,
D.Sc., President and Chief Executive Officer of Cara Therapeutics.
“As a next step, we plan to meet with the FDA to finalize the trial
design of Part B of this Phase 2/3 study and to initiate patient
recruitment later this year.”
“These exciting results underscore I.V. CR845’s
potential, if successfully developed, to become an approved therapy
in the U.S. for CKD patients suffering from UP,” said Gil
Yosipovitch, M.D., Professor of Dermatology, Miller School of
Medicine, and Director of the Miami Itch Center at the University
of Miami. “There is an unmet medical need for an effective
long-term therapy for treating this intractable pruritus and
providing meaningful improvement in the quality of life of these
patients under dialysis treatment.”
“This study demonstrated encouraging,
statistically significant improvements across quality of life
measures for hemodialysis patients with this condition,” said Mark
Unruh, M.D., Chair of the Department of Internal Medicine at the
University of New Mexico School of Medicine. “Importantly, these
improvements persisted for the entire eight-week treatment period,
with the anti-itch effect apparently sustained over time,
suggesting that CR845 has the potential to be an effective
treatment for this difficult condition, if successfully developed
and approved.”
I.V. CR845 Phase 2/3 UP Trial Design and
Top-line Results
Part A of the Phase 2/3 UP trial was a
randomized, double-blind, placebo-controlled trial of three doses
of I.V. CR845 (0.5 ug/kg, 1.0 ug/kg, and 1.5 ug/kg) administered
three times per week after dialysis over an eight-week treatment
period in 174 patients with moderate-to-severe UP.
The primary endpoint was the change from
baseline of the mean worst itching score for week eight (days
51-57) based on a validated 0-10 Numeric Rating Scale (NRS).
Patients receiving I.V. CR845 experienced a 68 percent greater
reduction from baseline in worst itch scores than those receiving
placebo (p-value<0.0019).
The secondary endpoint focused on quality of
life measures associated with pruritus using the Skindex-10 score,
a validated self-assessment scale with higher scores indicating
worse quality of life. Patients receiving I.V. CR845 experienced a
100 percent greater reduction from baseline in the average total
Skindex-10 score at week eight than those receiving placebo
(p-value<0.0007). The total average Skindex-10 score reflected
statistically significant reductions in each of the three
Skindex-10 domains; disease (p-value=0.0001), mood/emotional
distress (p-value=0.01), and social functioning
(p-value=0.009).
Overall, I.V. CR845 was well tolerated over the
eight-week treatment period and the unblinded Drug Safety
Monitoring Board did not report any significant drug-related events
during the course of the trial. The most common adverse events were
transient paresthesia (primarily mid-facial tingling or numbness)
and dizziness, as reported in previous clinical studies of I.V.
CR845.
Cara plans to meet with the U.S. Food and Drug
Administration (FDA) for an end-of-Phase 2 meeting to review the
results to determine an optimal dose to take into Part B of this
Phase 2/3 study, and define the broader path towards approval.
Pending discussions with the FDA, Part B of the study is intended
to be a randomized, double-blind, placebo-controlled trial of I.V.
CR845 administered three times per week after dialysis over a
12-week treatment period in up to 240 patients with
moderate-to-severe UP.
Conference Call
Cara management will host a conference call
today at 8:30 a.m. ET to discuss the trial results and next steps
for the program.
To participate in the conference call, please
dial 855-445-2816 (domestic) or 484-756-4300 (international) and
refer to conference ID 97080265. A live webcast of the call can be
accessed under "Events and Presentations" in the News &
Investors section of the Company's website at
www.caratherapeutics.com.
An archived webcast recording will be available
on the Cara website beginning approximately two hours after the
call.
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 estimate 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 60-70 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, which are
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 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 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
more than 600 subjects dosed to date, I.V. CR845 was found to be
well-tolerated, without incurring the dysphoric and psychotomimetic
side effects that have been reported with centrally-acting
(CNS-active) kappa opioid receptor agonists, and lacking the
respiratory depression and abuse liability of mu opioid receptor
agonists. Top-line data from a Phase 2b trial of CR845 in chronic
pain associated with osteoarthritis and a conditional power
analysis from an adaptive Phase 3 trial in postoperative pain are
expected in the second quarter of 2017.
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 peripheral kappa opioid receptors. Cara is
developing a novel and proprietary class of product candidates, led
by CR845, 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 initiation of Part B of the trial for I.V.
CR845 for UP, timing of a meeting with the FDA and any initiation
of enrollment of a Phase 3 trial for I.V.CR845 for UP, the ability
of these trials to demonstrate an extended patient benefit, the
potential for I.V. CR845 to be a therapeutic option for UP and the
expected timing for announcement of the results of other ongoing
clinical trials. 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’s filings with the Securities and
Exchange Commission, including the "Risk Factors" section of Cara’s
Annual Report on Form 10-K for the year ended December 31, 2016 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. Except to the extent required by law, Cara
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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