Cara Therapeutics Announces Publication of Difelikefalin (KORSUVA™ Injection) KALM™-1 Phase 3 Trial Results in the New En...
November 11 2019 - 7:00AM
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company
focused on developing and commercializing new chemical entities
designed to alleviate pruritus by selectively targeting peripheral
kappa opioid receptors, today announced that the New England
Journal of Medicine (NEJM) published full results from the
randomized, double-blind pivotal Phase 3 (KALM-1) trial of
difelikefalin (KORSUVA™ Injection) in patients undergoing
hemodialysis with moderate-to-severe chronic kidney
disease-associated pruritus (CKD-aP).
The paper, titled “A Phase 3 Trial of
Difelikefalin in Hemodialysis Patients with Pruritus,” summarizes
data from 378 patients, randomized to receive intravenous bolus
difelikefalin at a dose of 0.5 mcg/kg or placebo at the end of each
dialysis session, administered over a 12-week treatment period.
Overall, 51.9% of patients in the difelikefalin group achieved the
pre-specified primary outcome of a three point or greater
improvement in the weekly mean of the daily worst itch intensity
numeric rating scale (WI-NRS) versus 30.9% in the placebo group at
week 12. In an additional analysis conducted for NEJM, the imputed
proportion of patients achieving the primary outcome was 49.1% in
the difelikefalin group, as compared to 27.9% in the placebo group
(p<0.001) at week 12. Difelikefalin treatment also resulted in
statistically significant improvements in the proportion of
patients achieving a four point or greater improvement in WI-NRS,
as well as in itch-related quality of life measures, as assessed by
the 5-D itch and Skindex-10 scales, from baseline to week 12.
Diarrhea, dizziness, and vomiting were more common in the
difelikefalin group than the placebo group, consistent with earlier
clinical trials of difelikefalin in hemodialysis patients with
CKD-aP.
“I am impressed by the clinically meaningful
efficacy demonstrated in this Phase 3 trial of difelikefalin in
hemodialysis patients with chronic pruritus,” said Steven Fishbane,
M.D., Chief, Division of Kidney Disease and Hypertension, Northwell
Health, Professor of Medicine at Hofstra/Northwell, a KALM-1
clinical investigator and lead author of the NEJM paper. “Pruritus
is a significant problem for many of our CKD patients undergoing
hemodialysis and the present efficacy and safety data exhibited in
this trial suggest that difelikefalin, if approved, has the
potential to be an important drug to address this unmet need.”
About CKD-aPCKD-aP is an
intractable systemic itch condition that occurs with high frequency
and intensity in patients with chronic kidney disease undergoing
hemodialysis and peritoneal dialysis. Pruritus has also been
reported in patients with stage III-V CKD who are not 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 25 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 pruritus.1,2 Recent data from the ITCH
National Registry Study showed that among those with pruritus,
approximately 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 antipruritic treatments, such as
antihistamines and corticosteroids, 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.3 CKD-aP is
also an independent predictor of mortality among hemodialysis
patients, mainly related to increased risk of inflammation and
infections.
References:
- Pisoni RL, et al. Pruritus in
haemodialysis patients: international results from the Dialysis
Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial
Transplant. 2006; 21:3495-3505.
- Ramakrishnan K, 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.
- Mathur VS, et al. A
longitudinal study of Uremic Pruritus in hemodialysis
patients. Clin J Am Soc Nephrol. 2010;
5(8):1410-1419.
About Cara TherapeuticsCara
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, or 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 KORs located in the
peripheral nervous system, and on immune cells. In a Phase 3 and
two Phase 2 trials, KORSUVA (CR845/difelikefalin) Injection has
demonstrated statistically significant reductions in itch intensity
and concomitant improvement in pruritus-related quality of life
measures in hemodialysis patients with moderate-to-severe CKD-aP
and is currently being investigated in 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.
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
StatementsStatements 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 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 UrheimStern Investor
Relations, Inc.212-362-1200jane.urheim@SternIR.com
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