Current Report Filing (8-k)
June 30 2022 - 7:02AM
Edgar (US Regulatory)
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2022-06-28
2022-06-28
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
June 28, 2022
CARA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-36279 |
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75-3175693 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
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4 Stamford Plaza
107 Elm Street, 9th Floor
Stamford, Connecticut |
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06902 |
(Address of principal executive offices) |
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(Zip Code) |
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Registrant's telephone number, including area code: (203) 406-3700 |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title
of each class |
Trading
Symbol(s) |
Name
of each exchange on which registered |
Common stock, par value $0.001 per share |
CARA |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by
check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01. |
Regulation FD Disclosure. |
On June 30, 2022, Cara Therapeutics, Inc. (the “Company”)
issued a press release (the “Press Release”) announcing positive topline results from its KOMFORT Phase 2 clinical trial of
oral difelikefalin for the treatment of moderate-to-severe pruritus associated with Notalgia Paresthetica (“NP”) patients.
The Company will hold a conference call to discuss the results at 8:30 a.m. ET on June 30, 2022. A copy of the Press Release and the presentation
(the “NP Presentation”) to be discussed on the conference call are furnished as Exhibit 99.1 and Exhibit 99.2, respectively,
to this Current Report on Form 8-K and incorporated herein by reference.
On June 30, 2022, the Company made available an updated corporate presentation,
which can be found on the Company’s website (the “Corporate Presentation”). The Corporate Presentation is furnished
as Exhibit 99.3 and incorporated herein by reference.
The information furnished under this Item 7.01, including Exhibit 99.1,
Exhibit 99.2 and Exhibit 99.3, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934
(the “Exchange Act”) or subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference
into any of the Company’s filings with the Securities and Exchange Commission (“SEC”) under the Exchange Act or the
Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in
such a filing. The information shall not be deemed incorporated by reference into any other filing with the SEC made by the Company, regardless
of any general incorporation language in such filing.
Item 8.01. |
Other Information. |
On June 30, 2022, the Company issued the Press Release announcing positive
topline results from its KOMFORT Phase 2 clinical trial of oral difelikefalin for the treatment of moderate-to-severe pruritus associated
with NP patients.
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.
Primary Endpoint
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 versus -2.4 placebo, p=0.001) with significant improvement observed as early as Week 1 and sustained
through Week 8.
Other Endpoints
A statistically significantly greater
proportion of patients treated with oral difelikefalin achieved a ≥4-point improvement in WI-NRS score at Week 8 versus
placebo (41% difelikefalin versus 18% placebo, p=0.007).
Safety and Tolerability
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.
Item 9.01. |
Financial Statements and Exhibits. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CARA THERAPEUTICS, INC. |
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By: |
/s/ CHRISTOPHER POSNER |
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Christopher Posner |
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President and Chief Executive Officer |
Date: June 30, 2022
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