Cara Therapeutics Announces Presentation at American Society of Nephrology Kidney Week 2020
October 21 2020 - 4:01PM
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 results
from its KALM-2 pivotal Phase 3 trial of KORSUVA™
(CR845/difelikefalin) Injection in hemodialysis patients with
moderate-to-severe chronic kidney disease-associated pruritus
(CKD-aP) will be presented at the American Society of Nephrology
(ASN) Kidney Week 2020 annual meeting, which is being held
virtually from October 22-25, 2020.
Details for the oral presentation are as
follows:
Title: Efficacy and Safety of
Difelikefalin for Moderate-to-Severe CKD-Associated Pruritus: A
Global Phase 3 Study in Hemodialysis Patients
(KALM-2)Abstract Number: FR-OR24Date and
Time: Friday, October 23, 5 to 7 p.m.
ETPresenter: Thomas D. Wooldridge, M.D.,
Nephrology and Hypertension Associates, Ltd., Tupelo, MS
In April 2020, the Company announced positive
top-line results from KALM-2. The trial met the primary endpoint,
with a statistically significant proportion of patients on KORSUVA
Injection achieving a three-point or greater improvement from
baseline in the weekly mean Worst Itching Intensity Numeric Rating
Scale (NRS) versus placebo (p=0.02) at week 12. The trial also met
the key secondary endpoint, with a statistically significant
proportion of patients on KORSUVA Injection achieving a four-point
or greater improvement from baseline in the weekly mean Worst
Itching Intensity NRS versus placebo (p=0.01) at week 12. KORSUVA
Injection was generally well-tolerated through 12 weeks of
treatment with a safety profile consistent with prior clinical
trials.
The Company remains on track to submit a New
Drug Application for KORSUVA Injection to the U.S. Food and Drug
Administration in the fourth quarter of 2020.
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, 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 the body’s peripheral nervous system, as well as
certain immune cells. In two Phase 3 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). Cara has successfully
completed its Phase 2 trial of Oral KORSUVA for the treatment of
pruritus in patients with CKD and is currently conducting Phase 2
trials of Oral KORSUVA in atopic dermatitis and primary biliary
cholangitis patients with moderate-to-severe pruritus.
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
expected timing for the submission of the Company’s NDA for KORSUVA
Injection for CKD-aP, the Company’s ability to commercialize
KORSUVA Injection and the Company’s potential future growth and
success. 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 Therapeutics’ filings with the
Securities and Exchange Commission, including the “Risk Factors”
section of the Company’s most recent Quarterly Report on Form 10-Q
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. Cara Therapeutics undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were
made.
INVESTOR CONTACT:Janhavi
MohiteStern Investor Relations, Inc.212-362-1200
janhavi.mohite@SternIR.com
MEDIA CONTACT:Annie Starr6
Degrees973-415-8838 astarr@6degreespr.com
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