Cara Therapeutics Announces Successful End-of-Phase 2 Meeting with FDA for I.V. CR845 in Chronic Kidney Disease-Associated Pr...
October 16 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 the successful
completion of its End-of-Phase 2 Meeting with the U.S. Food and
Drug Administration (FDA). The Company, in consultation with the
FDA, has established the key elements of the Phase 3 program to
support a New Drug Application (NDA) for I.V. CR845 for the
treatment of moderate-to-severe chronic kidney disease-associated
pruritus (CKD-aP) in hemodialysis patients. The FDA previously
granted Breakthrough Therapy designation to I.V CR845 for
moderate-to-severe CKD-aP, for which there are currently no
approved therapies in the United States (U.S.).
“We are very pleased with the productive
guidance we have received from the FDA during our recent
End-of-Phase 2 meeting,” said Derek Chalmers, Ph.D., D.Sc.,
President and Chief Executive Officer of Cara Therapeutics. “We
expect to initiate our pivotal Phase 3 program of I.V. CR845 for
the treatment of CKD-aP in hemodialysis patients in the U.S. by the
end of 2017, and will continue working closely with the agency to
develop CR845 as a potential new therapeutic option for this highly
debilitating aspect of CKD as quickly as possible.”
The End-of-Phase 2 discussion was supported by
positive top-line results from an eight-week clinical trial of I.V.
CR845 in 174 hemodialysis patients with moderate-to-severe
pruritus. The trial met both 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 Ongoing Safety Trial of I.V.
CR845 in Hemodialysis Patients
The 52-week Phase 3 safety study, which was
initiated in the second quarter of 2017, is enrolling hemodialysis
patients with CKD-associated pruritus (CKD-aP) who previously
completed one of the Company’s prior studies (CR845-CLIN2101 Part A
or CR845-CLIN2005 Part B). This open-label trial is evaluating the
long-term safety of I.V. CR845 at the 0.5 mcg/kg dose, which met
both primary and secondary efficacy endpoints (reduction of itch
and improved quality of life, respectively) in the completed Phase
2 trial in hemodialysis patients with moderate-to-severe CKD-aP,
and is the selected dose for the planned Phase 3 pivotal trial.
About CKD-aP
CKD-aP is an intractable systemic itch condition
that occurs with the greatest frequency and intensity in chronic
kidney disease patients undergoing hemodialysis 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 CKD-aP to be
approximately 40 percent in patients with end-stage renal disease
(ESRD), with approximately 24 percent of patients reporting severe
pruritus. The majority of dialysis patients (approximately 60-70
percent) report pruritus, with 30 to 40 percent reporting moderate
or severe pruritus1,2.. Recent data from the ITCH National Registry
Study showed that among those with pruritus, 59 percent 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. CKD-aP is also an independent predictor
of mortality among hemodialysis patients, mainly related to
increased risk of inflammation and infections.
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 (KORs).
Cara is developing a novel and proprietary class of product
candidates, led by CR845, a first-in-class KOR agonist that targets
the body's peripheral nervous system. In Phase 2 trials, CR845 has
demonstrated statistically significant reductions in itch intensity
and concomitant improvement in quality of life measures in patients
with moderate-to-severe chronic kidney disease-associated pruritus.
Additionally, CR845 has demonstrated initial signs of efficacy in
patients with moderate-to-severe pain, without inducing many of the
undesirable side effects typically associated with currently
available opioid pain therapeutics.
References1. Pisoni RL, Wikstrom B, Elder SJ,
et al. Pruritus in haemodialysis patients: international results
from the Dialysis Outcomes and Practice Patterns Study (DOPPS).
Nephrol Dial Transplant. 2006;21:3495-3505.
2. Ramakrishnan et al. Clinical characteristics and
outcomes of end-stage renal disease patients with self-reported
pruritus symptoms. International Journal of Nephrology and
Renovascular Disease. 2014:7 1–12
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 timing of the initiation of the company’s
planned pivotal Phase 3 efficacy trial for the treatment of CKD-aP
in hemodialysis patients. 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 the planned clinical
trial may not be initiated as expected based on delays, for example
in onboarding the clinical trial sites and screening and enrolling
candidates. 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: Michael Schaffzin Stern
Investor Relations, Inc. 212-362-1200 michael@sternir.com
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