Current Report Filing (8-k)
June 24 2021 - 8:19AM
Edgar (US Regulatory)
0001595097
false
0001595097
2021-06-24
2021-06-24
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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 24, 2021
CORBUS
PHARMACEUTICALS HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
|
001-37348
|
|
46-4348039
|
(State
or other jurisdiction
of
incorporation)
|
|
(Commission
File
Number)
|
|
(IRS
Employer
Identification
No.)
|
500
River Ridge Drive, Norwood, MA
|
|
02062
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
Registrant’s
telephone number, including area code: (617) 963-0100
Not
Applicable
(Former
name or former address, if changed since last report.)
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. below):
☐
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
|
☐
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
|
☐
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
|
☐
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Title
of each class
|
|
Trading
Symbol(s)
|
|
Name
of each exchange on which registered
|
Common
Stock
|
|
CRBP
|
|
The
Nasdaq Global Market
|
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.
|
On
June 24, 2021, Corbus Pharmaceuticals Holdings, Inc. (the “Company”) issued a press release announcing results from its Phase
3 DETERMINE study of lenabasum in adults with dermatomyositis. A copy of the press release is attached hereto as Exhibit 99.1.
The
information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished
to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall
not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except
as shall be expressly set forth by a specific reference in such filing.
Item
8.01 Other Information.
On
June 24, 2021, the Company announced results from its Phase 3 DETERMINE study of lenabasum in adults with dermatomyositis.
Primary
endpoint:
The
study did not meet its primary endpoint of Total Improvement Score (TIS) at Week 28. Higher TIS values indicate greater overall improvement.
At Week 28, the lenabasum 20 mg twice daily group achieved a mean TIS of 28.3 versus the control group mean TIS of 26.7, p = 0.1965.
All subjects, including the control group, received standard background treatments, with 89% of dosed subjects receiving ≥ 1 immunosuppressive
or immunomodulating therapy. Additional pre-specified analyses of the overall effect of lenabasum 20 mg twice daily versus control group
on TIS through Week 52 showed a trend of beneficial effect of lenabasum, nominal p = 0.0795.
Additional
findings:
Dermatomyositis
patients have characteristic muscle weakness and inflammatory skin involvement. This study enrolled subjects with the two major types
of dermatomyositis - classic dermatomyositis with both muscle weakness and skin involvement and dermatomyositis with no significant muscle
weakness but with skin involvement. Improvement in muscle weakness is heavily weighted in the TIS score. In the overall study, higher
TIS scores were seen in those subjects who had muscle weakness (Manual Muscle Test-8 muscle group score < 142) and were treated with
lenabasum 20 mg twice daily versus the control group, nominal p = 0.0302. Conversely, the Cutaneous Dermatomyositis Activity and Severity
Index (CDASI) activity score, a secondary endpoint in this study, is a validated outcome that was designed to assess inflammatory skin
involvement in dermatomyositis. In the overall study, greater improvement (reduction) in CDASI activity scores was seen in subjects with
skin involvement but no muscle weakness who were treated lenabasum 20 mg twice daily versus the control group, nominal p = 0.0166. This
is a similar patient population and the same endpoint as was tested in our prior Phase 2 study (ClinicalTrials.gov Identifier: NCT02466243).
Effect
of lenabasum on lung function was a secondary endpoint in this study, and no statistically significant difference was seen at Week 28
in the lenabasum 20 mg twice daily group versus control group. In the overall study, other pre-specified analyses showed that subjects
on stable immunosuppressive therapies (> 1 year treatment duration) had an improvement in forced vital capacity compared to the control
group, nominal p = 0.0591.
Efficacy
results for the lenabasum 5 mg twice daily group were generally similar to those for the control group.
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.
|
CORBUS
PHARMACEUTICALS HOLDINGS, INC.
|
|
|
|
Dated:
June 24, 2021
|
By:
|
/s/
Yuval Cohen
|
|
Name:
|
Yuval
Cohen, PhD
|
|
Title:
|
Chief
Executive Officer
|
Corbus Pharmaceuticals (NASDAQ:CRBP)
Historical Stock Chart
From May 2024 to Jun 2024
Corbus Pharmaceuticals (NASDAQ:CRBP)
Historical Stock Chart
From Jun 2023 to Jun 2024