Full Press Release Details
Cara Therapeutics and Vifor Fresenius
Pharma Announce Positive Results From Global KALM-2
Pivotal Phase 3 Trial of KORSUVATM Injection
Hemodialysis Patients with Pruritus
significant improvement in primary endpoint of proportion of patients with three point or greater reduction in mean Worst Itching
Intensity NRS score vs. placebo (p=0.02) -
significant improvement in key secondary endpoint of proportion of patients with four point or greater reduction in mean worst
itching intensity NRS score vs. placebo (p=0.01) -
Injection NDA and MAA submission expected in the second half of 2020 -
to host conference call today at 8:30 a.m. ET -
STAMFORD, Conn. and St. Gallen, CH,
April 21, 2020 - Cara Therapeutics, Inc. (Nasdaq:CARA) and Vifor Fresenius Medical Care Renal Pharma (VFMCRP),
today announced positive topline data from Cara's 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).
"We are very pleased with the positive
topline data from our global, pivotal Phase 3 trial of KORSUVA Injection, which reinforce the robust results we reported from our
U.S. KALM-1 Phase 3 trial last year," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics.
"With these data in hand, we remain on track to submit our New Drug Application (NDA) for KORSUVA Injection in the second
half of this year to the U.S. Food and Drug Administration (FDA) and, working with our partner Vifor Fresenius Medical Care Renal
Pharma, plan to submit for Marketing Authorization Approval (MAA) to the European Medicines Agency (EMA) shortly thereafter."
continue to be very impressed by the robust efficacy of KORSUVA for the treatment of pruritus in our patients undergoing hemodialysis,"
said Steven Fishbane, M.D., Chief, Division of Kidney Disease and Hypertension,
Northwell Health and Professor of Medicine at Hofstra/Northwell. "Itching
is a real issue for our hemodialysis patients and there are no approved treatments in the U.S. or Europe so I am encouraged by
the potential of this drug to address a significant unmet need for our patients."
"We are delighted with this outcome
and congratulate the Cara team on the positive topline Phase 3 data on KORSUVA Injection in hemodialysis patients with moderate-to-severe
pruritus," said Stefan Schulze, Vifor Pharma President of Executive Committee and Chief Operating Officer. "KORSUVA
Injection has the potential to serve as a breakthrough therapeutic for treating this serious itching condition in hemodialysis
patients, and is a natural fit to our leading nephrology-focused product portfolio. We are committed to making KORSUVA Injection
available as quickly as possible to hemodialysis patients, who urgently need effective therapy."
CKD-aP is an intractable systemic itch
condition that occurs with high frequency and intensity in patients undergoing hemodialysis. Multiple studies estimate that at
least 40% of dialysis patients suffer from pruritus. The FDA has granted Breakthrough Therapy designation to KORSUVA Injection
for this indication.
KALM-2 Efficacy Data:
KALM-2 Safety and Tolerability:
KORSUVA Injection was generally well-tolerated
with a safety profile consistent with that seen in KALM-1 and the KORSUVA clinical program in patients with CKD-aP. Overall, the
incidence of adverse events (AEs) and serious AEs were similar across both KORSUVA and placebo groups. The most common treatment-emergent
AEs reported in >5% of patients were diarrhea (8.1% KORSUVA versus 5.5% placebo), falling (6.8% KORSUVA versus 5.1% placebo),
vomiting (6.4% KORSUVA versus 5.9% placebo), nausea (6.4% KORSUVA versus 4.2% placebo) and dizziness (5.5% KORSUVA versus 5.1 %
VFMCRP License Agreement
In May 2018, Cara licensed worldwide
rights, except in the U.S., Japan and South Korea, to commercialize KORSUVA Injection for the treatment of CKD-aP in dialysis patients
to VFMCRP, a company that specializes in nephrology therapies. Cara retains full development and commercialization rights for KORSUVA
Injection for the treatment of CKD-aP in the U.S. except in the dialysis clinics of Fresenius Medical Care North America (FMCNA),
where VFMCRP and Cara will promote KORSUVA Injection under a profit-sharing arrangement based on net FMCNA clinic sales recorded
by Cara. Cara will solely promote KORSUVA Injection in all non-FMC clinics in the U.S. and retain all profits from those sales.
Cara management will host a conference
call today at 8:30 a.m. ET to discuss the results of the study.
To participate in the conference call,
please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 1681438. A live webcast of the
call can be accessed under "Events & Presentations" in the News & Investors section of Cara's
website at www.CaraTherapeutics.com.
An archived webcast recording will be available
on the Cara website beginning approximately two hours after the call.
KALM-2 Phase 3 Trial Design
KALM-2 is a Phase 3, global, multicenter,
randomized, double-blind, placebo-controlled, 12-week trial (with a 52-week open label extension phase) designed to evaluate the
safety and efficacy of 0.5 mcg/kg KORSUVA (CR845/difelikefalin) Injection in 473 hemodialysis patients with moderate-to-severe
The primary efficacy endpoint is the proportion
of patients achieving at least a three-point improvement from baseline in the weekly mean of the daily 24-hour WI-NRS score at
Secondary endpoints include assessment
of the proportion of patients achieving four-point or greater improvement from baseline in weekly mean of the daily 24-hour WI-NRS
score at week 12, as well as itch-related quality of life changes measured using the validated self-assessment 5-D itch and
CKD-aP is an intractable systemic itch
condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing 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% in patients with end-stage renal disease (ESRD), with approximately
25% of patients reporting severe pruritus. The majority of dialysis patients (approximately 60 to 70%) report pruritus, with
30 to 40% reporting moderate or severe pruritus.1,2 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/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.
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 (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 CKD-aP.
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.
About Vifor Pharma and Vifor Fresenius Medical Care Renal
Vifor Pharma Group is a global specialty
pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. Vifor Pharma
Group consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius
Medical Care; Relypsa; and OM Pharma. Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN:
Vifor Fresenius Medical Care Renal Pharma
Ltd., a common company of Vifor Pharma Group and Fresenius Medical Care, develops and commercialises innovative and high quality
therapies to improve the life of patients suffering from chronic kidney disease (CKD) worldwide. The company was founded at the
end of 2010 and is owned 55% by Vifor Pharma Group and 45% by Fresenius Medical Care.
Forward-looking 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