Cara Receives Breakthrough Therapy Designation from FDA for I.V. CR845 for the Treatment of Chronic Kidney Disease-Associated...
June 23 2017 - 7:00AM
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 that the U.S.
Food and Drug Administration (FDA) has granted Breakthrough Therapy
designation to I.V. CR845 for the treatment of moderate-to-severe
uremic pruritus (UP) in chronic kidney disease (CKD) patients
undergoing hemodialysis.
“The FDA’s decision to grant Breakthrough
Therapy designation is recognition of both the significant unmet
medical need among CKD patients with UP and the potential of I.V.
CR845 to address it,” said Derek Chalmers, Ph.D., D.Sc., President
and Chief Executive Officer of Cara Therapeutics. “We have already
initiated our Phase 3 program and look forward to working closely
with the FDA to bring this potential new treatment option to
hemodialysis patients as quickly as possible.”
Breakthrough Therapy designation is granted to
expedite the development and review process for new therapies
addressing serious or life-threatening conditions, where
preliminary clinical evidence indicates that the drug candidate may
demonstrate substantial improvement over existing therapies on one
or more clinically significant endpoints.
This regulatory decision was supported primarily
by positive top-line results from Part A of a Phase 2/3 clinical
trial of I.V. CR845 in patients with UP. Part A of the trial met
its primary endpoint, with a 68 percent reduction in worst itching
scores versus placebo after an eight-week treatment period
(p<0.0019), and its secondary endpoint, with a 100 percent
improvement in quality of life domains versus placebo
(p<0.0007). I.V. CR845 was well-tolerated in the trial.
About the Safety Trial of I.V. CR845 in
Hemodialysis Patients
The 52-week Phase 3 study is enrolling up to 240
hemodialysis patients with CKD-associated pruritus who previously
completed one of the Company’s Phase 2/3 studies (CR845-CLIN2101
Part A or CR845-CLIN2005 Part B). This open-label trial will
evaluate the long-term safety of I.V. CR845 at the dose of
0.5mcg/kg, a dose that met both primary and secondary efficacy
endpoints (reduction of itch and improved quality of life,
respectively) in patients with moderate-to-severe uremic pruritus
(UP).
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 1200 subjects dosed to date, CR845 was observed 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.
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 impact
of breakthrough therapy designation on the development and
potential commercialization of I.V. CR845 for the treatment of
moderate to severe UP in CKD patients undergoing hemodialysis.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Such risks include the
risk that breakthrough designation may be rescinded if our clinical
development program no longer meets the criteria for breakthrough
designation, and fact that breakthrough therapy designation: does
not guarantee marketing approval of I.V. CR845; does not improve
the likelihood of the FDA’s granting of marketing approval for I.V.
CR845 compared to drugs considered for approval under conventional
FDA procedures; and does not guarantee a faster development process
or review determination by the FDA. Additional factors that could
cause actual results to differ from those expressed or implied by
forward-looking statements are described 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:
Joshua Rappaport
Stern Investor Relations, Inc.
212-362-1200
josh@sternir.com
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