Full Press Release Details
Reports Second Quarter 2021 Financial Results
- New Drug Application (NDA) Filing for
KORSUVA Injection in CKD-aP under Priority Review by U.S. Food and Drug Administration (FDA); PDUFA Target Action Date August 23,
- Conference call today at 4:30 p.m. ET
STAMFORD, Conn., August 9, 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 second quarter ended June 30, 2021.
"Having completed the late-cycle review
of our NDA for our lead asset KORSUVA Injection with the FDA during the second quarter of the year, we remain on track for an expected
Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021 and continue to be focused, along with our commercial
partner, Vifor Pharma, on preparation for the U.S. launch of KORSUVA Injection in the second half of 2021, if approved," said Derek
Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We also continue to make good progress in our
Oral KORSUVA programs across a range of patient populations where pruritus treatment remains a significant unmet need and, pending the
outcome of our scheduled End-of-Phase 2 meeting with the FDA, aim to initiate our first Oral KORSUVA Phase 3 program in mild-to-moderate
atopic dermatitis patients by year-end of 2021."
Second Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated
Pruritus (CKD-aP): Hemodialysis
In February 2021, the FDA accepted the filing
of the NDA for KORSUVA Injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. Shortly after this decision,
the FDA granted Priority Review for the NDA filing of KORSUVA Injection in March 2021 with an expected PDUFA target action date of
August 23, 2021. Following these decisions, the potential FDA approval and subsequent U.S. commercial launch of KORSUVA Injection
could take place in the second half of 2021. If approved, KORSUVA Injection would be the first treatment for CKD-aP in hemodialysis patients.
In March 2021, the Company and Vifor Fresenius
Medical Care Renal Pharma Ltd. (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 injection 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.
The Company is party to a license agreement with
Vifor (International) Ltd. (Vifor) dated October 2020 under which it granted Vifor an exclusive license to commercialize KORSUVA
Injection for the treatment of pruritus in hemodialysis patients in the United States under a Cara 60%, Vifor 40% profit-sharing
arrangement. Under the terms of the agreement, upon U.S. regulatory approval of KORSUVA Injection, the Company will be eligible
to receive a $50.0 million common stock investment at a 20% premium to the 30-day trailing average price of the Company's
common stock as of such date. In addition, the Company is eligible to receive payments of up to $240.0 million upon the achievement
of certain sales-based milestones.
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. The study did not meet its primary endpoint of Worst Itch - Numeric Rating Scale (WI-NRS) change from
baseline at week 12 or secondary endpoint of 4-point responder analysis in the intent to treat (ITT) patient population. However, 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.
The Company is scheduled to conduct an End of
Phase 2 Meeting with the FDA in the third quarter of 2021 and, subject to discussions with the FDA, plans to initiate a Phase 3 program
in mild-to-moderate AD patients by year-end 2021.
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.
The FDA indicated the acceptability of Stage 5 pre-dialysis CKD patients as a viable patient population for a Phase 3 trial. The FDA also
indicated the potential to use data from the Company's previous trials of KORSUVA Injection in dialysis patients to support an approval
based on a single Phase 3 clinical trial of Oral KORSUVA in the Stage 5 pre-dialysis population. The Company plans to meet with the FDA
in the fourth quarter of 2021, to discuss the potential inclusion of earlier stage CKD patients in a Phase 3 program.
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. Currently, the Phase 2 trial has exceeded 50% patient enrollment and is expected to be fully enrolled
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
of KORSUVA is available for its ongoing and planned clinical trials.
Based on guidelines from the Centers for
Disease Control and Prevention and the State of Connecticut, all Cara employees continue to work remotely, and business travel
has been restricted.
Upcoming Meeting Activities
The Company expects to make presentations at the
following upcoming conferences:
Second Quarter 2021 Financial Results
Cash, cash equivalents and marketable securities
at June 30, 2021 totaled $207.4 million compared to $251.5 million at December 31, 2020. The decrease in the balance primarily
resulted from cash used in operating activities of $44.7 million, partially offset by proceeds of $1.0 million from the exercise of stock
For the three months ended June 30, 2021,
net loss was $30.7 million, or $0.61 per basic and diluted share, compared to a net loss of $25.1 million, or $0.54 per basic and diluted
share, for the same period in 2020.
Revenues: There was no revenue for the
three months ended June 30, 2021, compared to $5.6 million during the same period of 2020. The Company recognized $5.1 million of
license and milestone fees revenue during the three months ended June 30, 2020, $4.5 million of which related to its license agreement
with VFMCRP and $0.6 million of which related to the achievement of a development milestone related to its license agreement with Chong
Kun Dang Pharmaceutical Corp. The Company also recognized $0.5 million of clinical compound revenue from the sales of clinical compound
for the three months ended June 30, 2020 to Maruishi Pharmaceutical Company Ltd. and VFMCRP.
Research and Development (R&D) Expenses: