Cara Therapeutics Announces No Modifications in Trial Size for Phase 2 Trial of Oral KORSUVA™ in Chronic Kidney Disease Pat...
July 22 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 the completion of an
interim statistical assessment of its Phase 2 trial of Oral
KORSUVA™ (CR845/difelikefalin) for the treatment of pruritus in
patients with stage III-V (moderate-to-severe) chronic kidney
disease (CKD). In addition, the Company announced that the trial is
now fully enrolled at 240 patients.
Based on the recommendation of the Independent
Data Monitoring Committee (IDMC), the trial does not require any
modifications to the original enrollment target of 240 patients.
The IDMC’s recommendation was based on the results of a
prespecified interim conditional power assessment conducted after
approximately 50% of the 240 patients had completed the designated
12-week treatment period.
“CKD-associated pruritus remains a significant
unmet need for approximately one-third of diagnosed CKD patients in
the United States,” said Derek Chalmers, Ph.D., D.Sc., President
and Chief Executive Officer of Cara Therapeutics. “We are very
pleased with the IDMC’s recommendation that the Phase 2 trial
proceed as planned with no modifications. As with our KALM-1 Phase
3 trial, we commend our clinical team for designing a well-powered
study that enrolled on schedule, and we look forward to reporting
topline data from the trial in the fourth quarter.”
Phase 2 Trial Design
The Phase 2, multicenter, randomized,
double-blind, placebo-controlled, 12-week trial is 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 versus placebo in
approximately 240 stage III-V CKD patients with moderate-to-severe
pruritus.
The primary efficacy endpoint is the change from
baseline in the weekly mean of the daily 24-hour Worst Itch
Numeric Rating Scale (NRS) score at Week 12 of the treatment
period. Secondary endpoints include 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
≥3 points with respect to the weekly mean of the daily 24-hour
Worst Itch NRS score at Week 12.
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. 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.
References:
- Centers for Disease Control and
Prevention: Chronic Kidney Disease (CKD) Surveillance Project.
National Health and Nutrition Examination Survey. 2014.
- Sukul N, et al. Pruritus in Chronic
Kidney Disease Patients: Early Results from CKDopps. ERA-EDTA
Abstract. December 2016.
- IMS Pruritus Market Landscape
Analysis. September 2014.
- 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 timing for reporting of topline data from
the Phase 2 trial of Oral KORSUVA. 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
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