Cara Therapeutics Announces Positive Topline Results from KOMFORT Phase 2 Trial of Oral Difelikefalin for the Treatment of Pruritus in Patients with Notalgia Paresthetica
June 30 2022 - 7:00AM
Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage
biopharmaceutical company leading a new treatment paradigm to
improve the lives of patients suffering from pruritus, today
announced positive topline results from its Phase 2
proof-of-concept clinical trial (KOMFORT) evaluating oral
difelikefalin for the treatment of moderate-to-severe pruritus in
patients with notalgia paresthetica (NP), a nerve disorder
characterized by chronic pruritus of the upper to middle back.
“We are pleased to have demonstrated clinical
proof of concept for oral difelikefalin in the treatment of
pruritus associated with notalgia paresthetica,” said Joana
Goncalves, M.D., Chief Medical Officer at Cara Therapeutics. “These
topline results coupled with the results from our other programs
support the broad development of oral difelikefalin across disease
areas regardless of the underlying cause of pruritus. We look
forward to completing our data analyses and discussing next steps
with the U.S. Food and Drug Administration.”
“With no approved treatments available for
notalgia paresthetica, the condition is challenging to manage and
burdensome for patients,” said Mark Lebwohl, M.D., the lead
investigator and Professor and Dean for Clinical Therapeutics and
Chairman Emeritus of the Department of Dermatology at Icahn School
of Medicine at Mount Sinai. “These are encouraging results that
underscore the potential for oral difelikefalin to be the first
treatment option to address pruritus associated with notalgia
paresthetica.”
Phase 2 Proof-of-Concept Trial Design
& Topline Results
The Phase 2 multicenter, randomized,
double-blind, placebo-controlled, 8-week study was designed to
evaluate the efficacy and safety of oral difelikefalin for
moderate-to-severe pruritus in approximately 120 patients with NP.
Patients were randomized to oral difelikefalin 2 mg taken twice
daily versus placebo for 8 weeks, followed by a 4-week active
extension period.
The primary efficacy endpoint was the change
from baseline in the weekly mean of the daily 24-hour Worst
Itch-Numeric Rating Scale (WI-NRS) score at Week 8. Other endpoints
included the ≥4-point responder analysis, itch-related quality of
life scores, and safety assessments.
Patients treated with oral difelikefalin
achieved the primary endpoint (-4.0 difelikefalin vs. -2.4 placebo,
p=0.001) with significant improvement observed as early as Week 1
and sustained through Week 8.
In addition, a statistically significantly
greater proportion of patients treated with oral difelikefalin
achieved a ≥4-point improvement in WI-NRS score at Week 8 vs.
placebo (41% difelikefalin vs. 18% placebo, p=0.007).
Oral difelikefalin was generally well tolerated
with a safety profile consistent with that seen in earlier clinical
trials. The most common treatment-emergent adverse events reported
in ≥5% of patients treated with oral difelikefalin and greater than
placebo were: nausea, headache, dizziness, constipation and urine
output increased.
Conference Call &
Webcast
Cara management will host a conference call and
live webcast today at 8:30 a.m. ET to discuss the positive topline
results.
To participate in the conference call, please
dial (855) 445-2816 (domestic) or (484) 756-4300 (international)
and refer to conference ID 6999079. 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 Pruritus Associated with Notalgia
Paresthetica
Notalgia paresthetica (NP) is a common, although
under-recognized, chronic, sensory neuropathy affecting the upper
back.1 It is estimated that chronic pruritus affects up to 13% of
the population in the United States, and about 8% of these patients
suffer from neuropathic itch, including NP.2,3 One of the hallmark
features of NP is chronic pruritus, which can be significantly
burdensome and undermines the affected patients’ quality of life
and overall well-being.3 The exact etiology of NP still has not
been fully elucidated; however, it is widely accepted that NP is a
sensory neuropathy caused by alteration and damage to thoracic
spinal nerves.3
The management of NP is challenging and is often
resistant to multiple therapies. There is currently no approved
treatment for NP and conventional treatments for pruritus, such as
antihistamines and topical steroids, are largely ineffective.4
References:
- Matthew Howard, Lukas Sahhar, Frank
Andrews, Ralph Bergman and Douglas Gin. Notalgia paresthetica: a
review for dermatologists. International J of Dermatology 2018,57,
388-392.
- Manuel P. Pereira, Hannah Lüling,
Annette Dieckhöfer, Sabine Steinke, Claudia Zeidler and Sonja
Ständer. Brachioradial Pruritus and Notalgia Paraesthetica: A
Comparative Observational Study of Clinical Presentation and
Morphological Pathologies. Acta DV 2018; 98:82-88.
- Mollanazar, N.K., Koch, S.D. &
Yosipovitch, G. Epidemiology of Chronic Pruritus: Where Have We
Been and Where Are We Going?. Curr Derm Rep 4, 20–29 (2015)
- Mirna Šitum, Maja Kolić, Nika
Franceschi and Marko Pećina. Notalgia Paresthetica. Acta Clin Croat
2018; 57:721-725.
- Ahmed Ansari, David Weinstein &
Naveed Sami. Notalgia paresthetica: treatment review and
algorithmic approach. Journal of Dermatological Treatment
2019.
About Cara Therapeutics
Cara Therapeutics is a commercial-stage biopharmaceutical
company leading a new treatment paradigm to improve the lives of
patients suffering from pruritus. The Company’s novel KORSUVA™
(difelikefalin) injection is the first and only FDA-approved
treatment for moderate-to-severe pruritus associated with chronic
kidney disease in adults undergoing hemodialysis. The Company is
developing an oral formulation of difelikefalin and has initiated
Phase 3 programs for the treatment of pruritus in patients with
non-dialysis dependent advanced chronic kidney disease and atopic
dermatitis. The Company has completed the placebo-controlled phase
of a Phase 2 proof-of-concept trial of oral difelikefalin for the
treatment of moderate-to-severe pruritus in patients with notalgia
paresthetica. A Phase 2 proof-of-concept trial in primary biliary
cholangitis patients with moderate-to-severe pruritus is ongoing.
For more information, visit www.CaraTherapeutics.com and follow the
company on Twitter, LinkedIn and Instagram.
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 Company’s planned future regulatory
submissions and potential future regulatory approvals, expected
timing of the initiation, enrollment and data readouts from the
Company’s planned and ongoing clinical trials, the potential
results of ongoing clinical trials, timing of future regulatory and
development milestones for the Company’s product candidates, the
potential for the Company’s product candidates to be alternatives
in the therapeutic areas investigated, including NP, and the
potential for oral difelikefalin to address additional pruritic
indications, the size and growth of the potential markets for
pruritus management, the Company’s expected cash reach, and the
potential impact of COVID-19 on the Company’s clinical development
and regulatory timelines and plans. 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 Annual Report on Form 10-K
for the year ending December 31, 2021 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, except as required by law.
MEDIA CONTACT:Annie Spinetta6
Degrees973-768-2170aspinetta@6degreespr.com
INVESTOR CONTACT:Iris Francesconi, Ph.D.Cara
Therapeutics203-406-3700investor@caratherapeutics.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