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 positive topline results
from its Phase 2 dose-ranging trial of Oral KORSUVA™
(CR845/difelikefalin) for the treatment of pruritus in patients
with stage III-V (moderate-to-severe) chronic kidney disease (CKD).
“CKD-associated pruritus remains a significant
unmet need for approximately one-third of diagnosed CKD patients in
the U.S.,” said Derek Chalmers, Ph.D., D.Sc., President and Chief
Executive Officer of Cara Therapeutics. “We are pleased that this
Phase 2 study has successfully identified an appropriate tablet
strength of Oral KORSUVA to carry forward into a pivotal Phase 3
registration program which we expect to initiate next year.”
“These exciting results underscore Oral
KORSUVA’s potential to be the first approved therapy in the U.S.
for CKD patients suffering from moderate-to-severe pruritus,” said
Gil Yosipovitch, M.D., Professor, Dr. Phillip Frost Department of
Dermatology and Cutaneous Surgery and Director of the Miami Itch
Center. “There is an unmet medical need for an effective long-term
therapy for treating intractable pruritus and the results from this
trial suggest Oral KORSUVA holds great promise for CKD
patients.”
Phase 2 Trial
The Phase 2, multicenter, randomized,
double-blind, placebo-controlled 12-week trial was designed to
evaluate the safety and efficacy of three dose levels (0.25 mg, 0.5
mg and 1 mg, once daily) of Oral KORSUVA vs. placebo (randomized
1:1:1:1) in approximately 240 stage III-V CKD patients with
moderate-to-severe pruritus.
The primary efficacy endpoint was the change
from baseline in the weekly mean of the daily 24-hour Worst Itching
Intensity Numeric Rating Scale (WI-NRS) score at Week 12 of
the treatment period for any of the three tablet strengths vs.
placebo. Secondary endpoints included change from baseline in
itch-related quality of life scores at the end of Week 12, as
assessed by the total Skindex-10 and 5-D itch scales, as well as
the proportion of patients achieving an improvement from baseline
of ≥3 points with respect to the weekly mean of the daily 24-hour
Worst Itch NRS score at Week 12.
Primary Endpoint: Patients treated with the 1 mg
tablet strength of Oral KORSUVA™ achieved the primary endpoint of
statistically significant reduction in weekly mean of the daily
WI-NRS scores vs. placebo after the 12-week treatment period (-4.4
KORSUVA vs. -3.3 placebo, p=0.018). The treatment effect was
statistically significant after two weeks of treatment and
sustained through the 12-week treatment period.
Secondary Endpoints: The proportion of patients
on 1 mg tablet strength achieving a 3 point or greater improvement
from baseline in the weekly mean of the daily WI-NRS score at week
12 was 72% vs. 58% for placebo but did not achieve statistical
significance.
Patients on 1 mg tablet strength showed positive
improvements vs. placebo in itch- related quality of life endpoints
as measured using self-assessment Skindex-10 and 5-D Itch scales
but did not achieve statistical significance.
Safety and Tolerability: Oral KORSUVA was
generally well-tolerated with a safety profile consistent with that
seen in earlier KORSUVA clinical trials. Overall, the incidence of
treatment emergent adverse events (AEs) were similar across KORSUVA
and placebo groups. The most common treatment emergent AEs reported
in >5% of patients in the 1 mg KORSUVA group vs. placebo were
dizziness (7.5% KORSUVA vs. 0% placebo), fall (6% KORSUVA vs. 0%
placebo), diarrhea (6% KORSUVA vs. 1.5% placebo) and constipation
(KORSUVA 6% vs. 3% placebo).
Conference Call
Cara management will host a conference call
today at 8:30 a.m. ET to discuss the topline results of the
trial.
To participate in the conference call, please
dial (855) 445-2816 (domestic) or (484) 756-4300 (international)
and refer to conference ID 8695654. A live webcast of the call can
be accessed under "Events & Presentations" in the News &
Investors section of the Company's website at
www.CaraTherapeutics.com.
An archived webcast recording will be available
on the Cara website beginning approximately two hours after the
call.
About CKD-Associated
Pruritus (CKD-aP)
CKD-aP is an intractable systemic itch condition
that occurs with high frequency and intensity in patients with CKD
undergoing hemodialysis and peritoneal dialysis. Pruritus has also
been reported in patients with stage III-V CKD who are not on
dialysis. According to estimates from the Centers for Disease
Control and Prevention, approximately 15% of the adult population
in the United States, or 30 million people, suffer from CKD, with
an estimated 50% in stages III-V. Of the patients diagnosed with
stage III-V CKD, approximately 25% suffer from moderate-to-severe
pruritus.1 Recent data from the ITCH National Registry Study showed
that among those with pruritus, approximately 59% experienced
symptoms daily or nearly daily for more than a year. Given its
association with CKD/end-stage renal disease, most afflicted
patients will continue to have symptoms for months or years with
currently employed antipruritic treatments, such as antihistamines
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.4
References:1. Centers for
Disease Control and Prevention: Chronic Kidney Disease (CKD)
Surveillance Project. National Health and Nutrition Examination
Survey. 2014.2. Sukul N, et al. Pruritus in Chronic Kidney
Disease Patients: Early Results from CKDopps. ERA-EDTA Abstract.
December 2016.3. IMS Pruritus Market Landscape
Analysis. September 2014.4. 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 (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
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, including the planned Phase 3 registration trials of
Oral KORSUVA, as well as the potential for Oral KORSUVA to be
approved for treatment of CKD-associated 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. 212-362-1200 jane.urheim@sternir.com
Cara Therapeutics (NASDAQ:CARA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cara Therapeutics (NASDAQ:CARA)
Historical Stock Chart
From Apr 2023 to Apr 2024