Cara Therapeutics Reports Continuation of Phase 3 Trial of I.V. CR845 in Postoperative Pain Following Interim Assessment
21 June 2017 - 9:00PM
- Trial will continue to test two doses of CR845
and aims to enroll up to 450 patients -
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 completion
of a prespecified interim conditional power analysis of its
adaptive Phase 3 trial of I.V. CR845. Based on the guidance of the
Independent Data Monitoring Committee (IDMC), the trial will
continue to test two doses of CR845 (1.0, and 0.5 μg/kg I.V.)
versus placebo in up to 450 patients undergoing abdominal surgery.
The IDMC also reviewed the available safety information, including
serum sodium levels, and confirmed that both doses of CR845 were
well tolerated with no significant changes in the monitored safety
parameters.
“We look forward to continuing to test both
doses of I.V. CR845 in our ongoing adaptive Phase 3 trial following
the IDMC's interim assessment analysis, and are encouraged by the
overall clinical safety profile of CR845 for use in the
postoperative setting,” said Joseph Stauffer, D.O., M.B.A., Chief
Medical Officer of Cara Therapeutics. “There remains a clear unmet
need for effective analgesic agents that lack the serious safety
risks inherent in current opioids. We anticipate completing
enrollment of this trial later this year.”
About the Ongoing CLIN3001 Postoperative
Pain Trial
The CLIN3001 Phase 3 trial is a multi-center,
randomized, double-blind, placebo-controlled, parallel-group
adaptive design trial with repeated doses of I.V. CR845 or placebo
administered both prior to and following abdominal surgery in male
and female patients. The trial is enrolling up to 450 patients at
30 clinical trial sites within the United States. Two doses of I.V.
CR845 (1.0, and 0.5μ g/kg I.V.) are being compared to
placebo. The primary efficacy measure is the Change in Pain
Intensity over the 24-hour postoperative period (AUC-24) using the
patient-reported Numeric Rating Scale (NRS) score collected at
prespecified time points through 24 hours. Postoperative nausea and
vomiting (PONV) will be evaluated as a secondary efficacy
measure.
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. Top-line data from a Phase 2b trial of Oral CR845 in
chronic pain associated with osteoarthritis 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 opioid 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 completion of the ongoing CLIN3001
postoperative pain trial of I.V. CR845 and the safety and efficacy
results of the ongoing CLIN3001 clinical trial. 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:
Joshua Rappaport
Stern Investor Relations, Inc.
212-362-1200
josh@sternir.com
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