Full Press Release Details
Therapeutics Reports Third Quarter 2021 Financial Results
- KORSUVA (CR845/difelikefalin)
injection Approved as First and Only Treatment for Chronic Kidney Disease-associated Pruritus (CKD-aP) in Adult Hemodialysis Patients
by U.S. Food and Drug Administration (FDA) -
- Christopher Posner Appointed President
and Chief Executive Officer Effective November 9th, 2021 -
- Conference call today at 4:30 p.m. ET
STAMFORD, Conn., Nov. 8, 2021 - 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 (KORs), today announced financial results and operational
highlights for the third quarter ended September 30, 2021.
"I am excited to be joining Cara at a transformational
point for the Company as it prepares for the commercial launch of KORSUVA injection for the treatment of moderate-to-severe pruritus associated
with chronic kidney disease in hemodialysis patients in the first half of 2022," said Christopher Posner, Cara's newly appointed
President and Chief Executive Officer. "As Cara continues to develop Oral KORSUVA across multiple patient populations, I believe
the Company is well-positioned to become the leader in the treatment of itch-dominant medical conditions such as atopic dermatitis."
"In the third quarter of 2021, Cara made
significant progress across our development programs, culminating with the FDA approval of KORSUVA injection for moderate-to-severe pruritus
associated with chronic kidney disease in hemodialysis patients," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive
Officer of Cara Therapeutics. "We are also making important clinical and regulatory progress with our Oral KORSUVA programs. Following
recent guidance from the FDA, we aim to initiate Phase 3 programs with Oral Korsuva for the treatment of moderate to severe pruritus in
both atopic dermatitis and non-dialysis dependent chronic kidney disease patients in the first quarter of 2022. Finally, I would
like to welcome Chris as Cara's new President and CEO. Having worked closely with Chris as a Cara board member, I am confident
in his ability to lead the Company through its next phase of development as an early commercial-stage biopharmaceutical company."
Third Quarter and Recent Developments:
Leadership Appointments
In November 2021, the Company announced the
appointment of Christopher Posner as President and Chief Executive Officer of Cara Therapeutics, effective November 9, 2021. Mr. Posner
joins the Company from LEO Pharma, Inc., the US affiliate of LEO Pharma A/S, a global leader in medical dermatology, where he was
President and Chief Executive Officer. Mr. Posner succeeds Dr. Derek Chalmers, who will transition to a Senior Advisor Role
KORSUVA Injection: Chronic Kidney Disease-Associated
Pruritus (CKD-aP): Hemodialysis
In August 2021, the FDA approved KORSUVA
injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis, making
it the first and only therapy currently approved by the FDA for treatment of this indication. The New Drug Application for KORSUVA injection
received Priority Review by the FDA, granted to therapies that, if approved, would offer significant improvements in the safety or effectiveness
of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications, and was supported by positive
data from two pivotal Phase 3 trials and supportive data from an additional 32 clinical studies.
Following the FDA approval of KORSUVA injection,
the Company has been collaborating with its commercial partner, Vifor Pharma, on the promotional launch of KORSUVA injection in the United
States. In September 2021, Vifor Pharma and Cara submitted the required documentation to the U.S. Centers for Medicare and Medicaid
Services (CMS) to secure reimbursement for KORSUVA injection. Vifor Pharma expects to initiate the commercial launch of KORSUVA injection
in the first half of 2022, subject to CMS timelines.
In October 2020, Vifor Pharma and Cara agreed
to an exclusive license to commercialize KORSUVA in the United States. That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing
arrangement in non-Fresenius Medical Care clinics in the U.S. Under the terms of this agreement, the Company received a $50.0 million
common stock investment from Vifor in October 2021 at a 20% premium to the 30-day trailing average price of the Company's common
stock for achievement of U.S. regulatory approval of KORSUVA injection. In addition, the Company is eligible to receive up to $240.0 million
upon the achievement of certain sales-based milestones. Under another existing agreement, Vifor Fresenius Medical Care Renal Pharma Ltd.
(VFMCRP) and the Company agreed to market KORSUVA injection to Fresenius Medical Care North America dialysis clinics in the U.S. under
a Cara 50%, Vifor Pharma 50% profit-sharing arrangement. In October 2021, the Company received a $15.0 million cash payment based
on the achievement of U.S. regulatory approval of KORSUVA injection.
In March 2021, the Company and VFMCRP announced
that the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for difelikefalin injection
for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients. The EMA will review the application under
the centralized marketing authorization procedure. If approved, difelikefalin would receive marketing authorization in all member states
of the European Union (EU), as well as in Iceland, Liechtenstein, and Norway. The EMA is expected to render a decision on the EU MAA in
the second quarter of 2022.
Oral KORSUVA: Atopic Dermatitis (AD)
In April 2021, the Company announced top-line
results from its Phase 2 KARE dose-ranging clinical trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in mild-to-severe
atopic dermatitis patients. While the study did not meet its primary endpoint, in a pre-specified analysis of mild-to-moderate (BSA <10%)
AD patients (64% of ITT patient population), the study met its primary endpoint of WI-NRS change and secondary endpoint of 4-point responder
analysis in this patient population. Additionally, a statistically significant improvement was demonstrated in the 4-point responder analysis,
which we expect will be the Phase 3 registrational endpoint, in mild-to-moderate AD patients, with 32% of KORSUVA-treated patients achieving
a greater than 4-point reduction vs. 19% in placebo group (p=0.03). Oral KORSUVA was generally well-tolerated across all doses.
In the third quarter, the Company held an End-of-Phase
2 Meeting with the FDA to discuss the results from its Phase 2 KARE dose-ranging clinical trial of Oral KORSUVA for the treatment of moderate-to-severe
pruritus in atopic dermatitis patients. Based on meeting guidance, the Company plans to initiate a Phase 3 program in AD patients in the
first quarter of 2022.
Oral KORSUVA: Non-Dialysis Dependent (NDD)
In April 2021, the Company held an End-of-Phase
2 Meeting with the FDA to discuss the results of the Phase 2 trial of Oral KORSUVA in NDD CKD-aP and the potential Phase 3 program. Based
on meeting guidance, the FDA indicated the acceptability of Stage 5 pre-dialysis CKD patients as a viable patient population for a Phase
In November 2021, the FDA provided written
guidance indicating the patient population can be expanded to include the group of Stage 4 pre-dialysis patients with advanced CKD in
a registration program consisting of two pivotal Phase 3 clinical trials. The Company expects to initiate this registration program in
the first quarter of 2022.
Oral KORSUVA: Chronic Liver Disease-Associated
Pruritus (CLD-aP): Primary Biliary Cholangitis (PBC)
The Company is currently conducting a Phase 2
trial of Oral KORSUVA for the treatment of pruritus in patients with hepatic impairment due to PBC. The trial is evaluating the safety
and efficacy of Oral KORSUVA (1.0 mg tablet, twice daily) versus placebo for 16 weeks. The Company continues to screen patients in this
ongoing Phase 2 trial and, primarily due to the ongoing effects of the COVID-19 pandemic on patient enrollment, currently expects to report
top-line data in the first half of 2022.
Oral KORSUVA: Notalgia Paresthetica (NP)
The Company initiated a Phase 2 trial of Oral
KORSUVA for the treatment of moderate-to-severe pruritus in patients suffering from NP, a nerve disorder characterized by chronic pruritus
of the upper back, in early 2021. The Phase 2 trial remains on track to be fully enrolled by year-end.
The Phase 2 multicenter, randomized, double-blind,
placebo-controlled 8-week study is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in approximately
120 subjects with NP. Subjects will be randomized to receive Oral KORSUVA 2.0 mg twice daily versus placebo for 8 weeks, followed by a
4-week active extension period. The primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24-hour WI-NRS
score at week 8 of the treatment period. Secondary endpoints include change from baseline in itch-related quality of life scores and a
change from baseline in itch-related sleep disturbance subscale at the end of week 8.
COVID-19 Impacts and Business Operations
Due to the ongoing COVID-19 pandemic and in accordance
with the FDA's updated guidance for conducting clinical trials, the Company has implemented numerous clinical and operational measures
to prioritize the health and safety of patients, employees and study investigators and minimize potential disruptions to its ongoing clinical
studies. The Company is working closely with its clinical and commercial manufacturing partners to continue to ensure sufficient supply