Cara Therapeutics Announces Completion of Interim Statistical Assessment and Small Increase in Target Enrollment for KALM-2 P...
14 October 2019 - 10:00PM
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company
focused on developing and commercializing new chemical entities
with a primary focus on the treatment of pruritus by selectively
targeting peripheral kappa opioid receptors, today announced the
completion of an interim statistical assessment of its pivotal
KALM-2 Phase 3 global clinical trial of KORSUVA™
(CR845/difelikefalin) Injection in hemodialysis patients with
moderate-to-severe chronic kidney disease-associated pruritus
(CKD-aP).
Based on the Independent Data Monitoring
Committee’s (IDMC) recommendation, the size of the trial will be
increased by approximately 20 percent, from an original enrollment
target of 350 patients to 430 patients, to maintain the
pre-specified statistical power of 90 percent or greater on the
trial’s primary endpoint. The IDMC charter allowed for the trial
size to be increased up to a maximum of 500 patients. The IDMC’s
recommendation was based on the results of a prespecified interim
conditional power assessment conducted after approximately 50
percent of the targeted patient number completed the designated
12-week treatment period.
“The IDMC recommendation to increase the target
enrollment of KALM-2 aligns with our objective to maintain similar
statistical power in this global trial to that of our positive
KALM-1 US trial,” said Derek Chalmers, Ph.D., D.Sc., President and
Chief Executive Officer of Cara Therapeutics. “As we have already
randomized a significant number of patients in KALM-2, beyond the
initial target enrollment of 350, we expect the trial to be fully
enrolled by the end of this quarter and remain on track to file our
New Drug Application (NDA) for KORSUVA Injection for the treatment
of moderate-to-severe CKD-aP in hemodialysis patients in the second
half of 2020.”
KALM-2 Phase 3 Trial Design
The Phase 3, global, multicenter, randomized,
double-blind, placebo-controlled, 12-week trial (with a 52-week
open label extension phase) is designed to evaluate the safety and
efficacy of 0.5 mcg/kg KORSUVA (CR845/difelikefalin) Injection
in 350 hemodialysis patients with moderate-to-severe pruritus.
The primary efficacy endpoint is the proportion
of patients achieving at least a 3‑point improvement from baseline
in the weekly mean of the daily 24‑hour Worst Itching Intensity
Numeric Rating Scale (WI-NRS) score at week 12. Secondary
endpoints include assessment of the proportion of patients
achieving >4-point improvement from baseline in weekly mean of
the daily 24-hour WI-NRS score at week 12 as well as
itch-related quality of life changes measured using the validated
self-assessment 5-D itch and Skindex-10 scales.
The pivotal KALM-1 Phase 3 US trial is complete
and topline data were reported in May 2019. The trial met the
primary endpoint, with a statistically significant improvement in
the proportion of patients on KORSUVA Injection achieving a 3-point
or greater improvement in the mean WI-NRS score versus placebo
(p=0.000019). The trial also met all secondary endpoints and
KORSUVA Injection was generally well-tolerated through 12 weeks of
treatment with a safety profile consistent with prior clinical
trials.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage
biopharmaceutical company focused on developing and commercializing
new chemical entities designed to alleviate pruritus by selectively
targeting peripheral kappa opioid receptors (KORs). Cara is
developing a novel and proprietary class of product candidates, led
by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist
that targets the body's peripheral nervous system, as well as
certain immune cells. In both Phase 3 and Phase 2 trials, KORSUVA
Injection has demonstrated statistically significant reductions in
itch intensity and concomitant improvement in quality of life
measures in hemodialysis patients with moderate-to-severe chronic
kidney disease-associated pruritus (CKD-aP). KORSUVA Injection is
currently being investigated in pivotal Phase 3 trials in
hemodialysis patients with CKD-aP. Oral KORSUVA is in Phase 2
trials for the treatment of pruritus in patients with CKD, atopic
dermatitis and primary biliary cholangitis (PBC).
The FDA has conditionally accepted KORSUVA™ as
the trade name for difelikefalin injection. CR845/difelikefalin is
an investigational drug product and its safety and efficacy have
not been fully evaluated by any regulatory authority.
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
ongoing trials and future development of the Company’s product
candidates, including the timing for completion and reporting of
topline results of Cara’s KALM-2 Phase 3 clinical trial, the timing
for filing an NDA, and the potential for KORSUVA to be a
therapeutic option for pruritus. 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, 2018 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: Jane Urheim Stern Investor
Relations, Inc.212-362-1200jane.urheim@SternIR.com
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