Full Press Release Details
Cara Therapeutics Reports First Quarter 2022
KORSUVA (difelikefalin) injection
U.S. commercial launch began in April 2022 and is tracking to expectation
Kapruvia (difelikefalin) approved
by European Commission for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis
patients, triggering $15M milestone payment to Cara
Top-line data from Phase 2 proof-of-concept
trial of Oral KORSUVA (difelikefalin) in notalgia paresthetica expected in 2Q 2022
Oral KORSUVA (difelikefalin) Phase 3 pruritus
programs in non-dialysis dependent advanced chronic kidney disease and atopic dermatitis underway
Conference call today at 4:30 p.m. ET
STAMFORD, Conn., May 9, 2022 - Cara
Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the
lives of patients suffering from pruritus, today announced financial results and operational highlights for the first quarter ended March
"We kicked off 2022 with substantial progress
and execution of our mission to establish Cara Therapeutics as the leader in the treatment of chronic pruritus," said Christopher
Posner, President and Chief Executive Officer of Cara Therapeutics. "In collaboration with our commercial partner Vifor Pharma,
KORSUVA (difelikefalin) injection has launched in the U.S. and early performance indicators are in line with our expectations.
Specifically, KORSUVA injection is available to be ordered by dialysis clinics nationwide, nephrologists are aware of KORSUVA injection
and are ready and starting to prescribe, and patient outreach is expanding through additional channels. In April, the European Commission
and the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to Kapruvia (difelikefalin),
making it the first approved therapy in Europe for the treatment of moderate-to-severe pruritus associated with chronic kidney disease
in adult hemodialysis patients."
Mr. Posner continued, "We're also
pleased with the progress across our Oral KORSUVA (difelikefalin) programs in multiple pruritus indications, which we believe represent
significant market opportunities and tremendous patient needs. As discussed during our R&D Day, we initiated Phase 3 programs for
pruritus associated with non-dialysis dependent advanced chronic kidney disease and atopic dermatitis. During this second quarter, we
look forward to reporting top-line data from our Phase 2 proof-of-concept trial in notalgia paresthetica, in which we're looking
for an efficacy signal. Lastly, we expect to have top-line data from our Phase 2 trial in primary biliary cholangitis in the second half
of 2022. Our solid financial footing, first-of-its-kind commercial product in KORSUVA injection and Oral KORSUVA (difelikefalin) pipeline
put us on the path to create significant value and future growth."
First Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated
Pruritus: Hemodialysis
In April 2022, the Company and its commercial
partner, Vifor Pharma, commercially launched KORSUVA (difelikefalin) injection in the U.S. for the treatment of moderate-to-severe pruritus
associated with chronic kidney disease (CKD) in adults undergoing hemodialysis. Transitional Drug Add-On Payment Adjustment (TDAPA) and
the J-code for KORSUVA injection were effective as of April 1, 2022. Vifor's field force of roughly 100 representatives has shifted
its promotional efforts from patient identification to promoting KORSUVA injection. Furthermore, Vifor has shipped initial stocking orders
of KORSUVA injection to the distribution channel.
In April 2022, the European Commission granted
marketing authorization to Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus associated with
CKD in adult hemodialysis patients. The marketing authorization approves Kapruvia for use in all member states of the
European Union plus Iceland, Liechtenstein and Norway. Also in April, the Medicines and Healthcare products Regulatory Agency (MHRA)
granted a UK Marketing Authorization. The first market launches in Europe are expected in the second half of 2022. This EU approval triggered
a $15 million milestone payment to Cara.
Oral KORSUVA (difelikefalin): Pruritus Associated
with Non-Dialysis Dependent Advanced Chronic Kidney Disease
The Company initiated a Phase 3 program of Oral
KORSUVA (difelikefalin) in patients with advanced CKD stages 4 or 5 with moderate-to-severe pruritus who are not on dialysis. The Phase
3 program is comprised of two identical 12-week, double-blind, placebo-controlled studies, known as KICK 1 and KICK 2. Each study is expected
to enroll approximately 400 patients who will be randomized 1:1 to either Oral KORSUVA (difelikefalin) 1 mg once daily or placebo. The
primary endpoint is the proportion of patients with 4-point improvement at Week 12 from baseline in the Worst Itch Numeric Rating
Scale (WI-NRS) score. The Company expects to report top-line results in the second half of 2024.
After the initial 12-week treatment period, patients
are allowed to enter the safety extension. Patients will be re-randomized to either Oral KORSUVA (difelikefalin) or placebo for up to
Oral KORSUVA (difelikefalin): Atopic Dermatitis
The Company initiated a Phase 3 program for Oral
KORSUVA (difelikefalin) as an adjunctive therapy to topical corticosteroids (TCS) in atopic dermatitis patients with moderate-to-severe
pruritus. The program is comprised of two studies, known as KIND 1 and KIND 2. Both studies are double-blind, controlled, 12-week studies
with patients allowed to roll over to 52-week open-label safety extensions. KIND 1 is composed of two parts, Part A and Part B. Part A
is expected to include 280 patients who will be randomized equally to four arms - Oral KORSUVA (difelikefalin) 0.25 mg twice daily
+ TCS, Oral KORSVUA (difelikefalin) 0.5 mg twice daily + TCS, placebo twice daily + TCS, and placebo twice daily + vehicle. At the end
of the 12-week treatment period in Part A, the Company expects to have an internal data readout in the second half of 2023, to inform
the dose and sample size to initiate Part B and KIND 2.
Oral KORSUVA (difelikefalin): Notalgia Paresthetica
The Company is evaluating the efficacy and safety
of Oral KORSUVA (difelikefalin) for moderate-to-severe pruritus in approximately 120 patients with notalgia paresthetica (NP) in a Phase
2 proof-of-concept trial. In this multicenter, randomized, double-blind, placebo-controlled 8-week trial, patients are randomized to receive
Oral KORSUVA (difelikefalin) 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 itch-related quality of life scores and sleep assessments. The Company expects to report top-line results
from this trial in the second quarter of 2022.
Oral KORSUVA (difelikefalin): Chronic Liver
Disease-Associated Pruritus: Primary Biliary Cholangitis
The Company is currently conducting a proof-of-concept
Phase 2 clinical trial of Oral KORSUVA (difelikefalin) for the treatment of pruritus in patients with hepatic impairment due to primary
biliary cholangitis (PBC). The trial is evaluating the safety and efficacy of Oral KORSUVA (difelikefalin) (1.0 mg tablet, twice daily)
versus placebo for 16 weeks. The Company expects to report top-line data in the second half of 2022.
Upcoming Meeting Activities:
The Company expects to make presentations at the
following upcoming conferences:
First Quarter 2022 Financial Results
Cash, cash equivalents and marketable securities
at March 31, 2022 totaled $209.6 million compared to $236.8 million at December 31, 2021. The decrease in the balance primarily resulted
from $25.5 million of cash used in operating activities.
For the first quarter of 2022, net loss was $27.7
million, or $(0.52) per basic and diluted share, compared to net loss of $23.3 million, or ($0.47) per basic and diluted share, for the
same period in 2021.
Revenues: Total revenue was $4.8 million
for the three months ended March 31, 2022, compared to $1.9 million during the same period of 2021. Revenue consisted of:
Cost of Goods Sold (COGS): Through February
2022, the Company had not recorded any COGS related to its commercial supply revenue as all inventory costs were incurred prior to receipt
of regulatory approval of KORSUVA injection and, accordingly, were expensed as incurred. In March 2022, the Company recorded commercial
supply revenue of $2.5 million, with associated COGS of $2.1 million as these inventory costs were incurred subsequent to the receipt
of regulatory approval of KORSUVA injection.
Research and Development (R&D) Expenses:
R&D expenses were $21.3 million for the three months ended March 31, 2022 compared to $19.1 million in the same period of 2021.
The higher R&D expenses in 2022 were principally due to increases in direct clinical trial costs and related consultant costs and
payroll related costs, partially offset by a decrease in stock-based compensation expense.