Cara Therapeutics Completes Enrollment of KALM-1 Pivotal Phase 3 Trial Of KORSUVA™ (CR845/ difelikefalin) Injection in Hemo...
January 07 2019 - 7:00AM
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
completion of enrollment in the KALM-1 Phase 3 trial of KORSUVA™
(CR845/ difelikefalin) Injection in hemodialysis patients with
moderate-to-severe chronic kidney disease-associated pruritus
(CKD-aP). More than 350 hemodialysis patients with CKD-aP have now
been randomized across approximately 60 clinical sites in the
United States.
“Completion of enrollment in the first pivotal
Phase 3 trial is an important milestone toward our goal of
developing KORSUVA™ Injection as a first-in-class therapeutic for
hemodialysis patients suffering from pruritus,” said Derek
Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of
Cara Therapeutics. “We are pleased that our development team was
able to enroll the trial within our projected timelines, and we
look forward to reporting top-line data in the second quarter of
this year.”
KORSUVA™ Injection Phase 3 Program
Update
KALM-1 Phase 3 Trial
KALM-1 is a multicenter, randomized,
double-blind, placebo-controlled 12-week treatment trial in the
U.S. with a 52-week open label extension phase that 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 Itch Numeric Rating
Scale (NRS) score at week 12. In a completed Phase 2 trial,
the proportion of patients with an improvement from baseline in the
weekly mean Worst Itch NRS score of ≥3 points at week 8 was
statistically significantly higher in the CR845/difelikefalin 0.5
mcg/kg group compared to the placebo group (64% vs. 29%;
p<0.01). 1
Secondary endpoints include assessment of
itch-related quality of life changes measured using the validated
self-assessment 5-D itch and Skindex-10 scales, as well as the
proportion of patients achieving > 4-point improvement from
baseline in weekly mean of the daily 24-hour Worst Itch NRS score
at week 12.
KALM-2 Phase 3 Trial
In August 2018, Cara announced the dosing of the
first patient in its second Phase 3 efficacy trial (KALM-2), which
is similar in design to the KALM-1 trial and will support
regulatory filings for approvals worldwide. This global Phase 3
trial is designed to enroll hemodialysis patients with
moderate-to-severe pruritus in the United States, as well as
multiple countries in Europe and Asia Pacific. Based on the current
patient enrollment rate and future projections, the Company expects
to report top-line data from this trial in the second half of
2019.
Phase 3 Safety Trial
In 2017, the Company initiated a 52-week Phase 3
safety trial that is designed to enroll up to 240 hemodialysis
patients with CKD-aP. This open-label trial is evaluating the
long-term safety of KORSUVA (CR845/ difelikefalin) Injection at the
dose of 0.5mcg/kg and has enrolled more than 200 patients. Thus
far, over 100 patients have completed at least six months of
treatment, with approximately 40 percent of these through the
one-year treatment period. To date, the safety and tolerability
have been consistent with data reported in Phase 2 trials of
KORSUVA Injection in hemodialysis patients with
CKD-aP. Additionally, based on a recent Independent Data
Safety Monitoring Board evaluation, no new safety signals have been
observed.
References:
- Data presentation at 2017 American Society of Nephrology’s
Annual Meeting (Kidney Week 2017).
About Cara Therapeutics
Cara Therapeutics is a clinical-stage
biopharmaceutical company focused on developing and commercializing
new chemical entities designed to alleviate pruritus and pain 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 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), and is currently being
investigated in Phase 3 trials in hemodialysis patients with
CKD-aP. Additionally, in a recently completed Phase 2/3 trial in
post-operative patients, I.V. CR845/difelikefalin demonstrated
reduction in moderate-to-severe pain, while also reducing the
incidence and intensity of nausea and vomiting throughout the
post-operative period.
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 of Cara’s Phase 3 clinical trials, and the potential of
CR845 to address medical needs in a range of pruritic conditions,
including CKD-aP. 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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