CORBUS PHARMACEUTICALS HOLDINGS, INC. (CRBP) Files An 8-K Regulation FD Disclosure
Item7.01.
| Regulation FD Disclosure. |
On November 14, 2016, Corbus Pharmaceuticals Holdings, Inc. (the
Company) announced that it was hosting a conference call to
provide an update on the Companys Phase 2 diffuse cutaneous
systemic sclerosis (systemic sclerosis) clinical program.A copy
of the press release announcing the conference call is attached
hereto as Exhibit 99.1.The Company is using the slides attached
hereto as Exhibit 99.2 in connection with the conference call.
The information in this Current Report on Form 8-K under Item
7.01, including the information contained in Exhibits 99.1 and
99.2, 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.
Item8.01. |
Other Events |
On November 14, 2016, the Company announced positive topline
results from its Phase 2 study evaluating Resunab (JBT-101) for
the treatment of diffuse cutaneous systemic sclerosis (systemic
sclerosis). JBT-101 out-performed placebo in the American College
of Rheumatology (ACR) Combined Response Index in diffuse
cutaneous Systemic Sclerosis (CRISS) score, reaching 33% at week
16, versus 0% for placebo. The higher the CRISS score the greater
the improvement; a CRISS score 20% (CRISS20) can be considered a
medically meaningful improvement. The difference in CRISS scores
between JBT-101 and placebo groups over the trial period was
significant (p = 0.044). Differences in categorical levels of
CRISS responses and changes from baseline in the five individual
domains of the CRISS score also supported clinical benefit of
JBT-101.
The multi-center, double-blind, randomized, placebo-controlled
Phase 2 study evaluated JBT-101s clinical benefit and safety in
27 subjects who received JBT-101 and 15 who received
placebo.Subjects had disease duration up to 6 years and were
allowed to receive stable doses of immunosuppressive drugs during
this study.Subjects were randomized (2 to 1 overall JBT-101 to
placebo ratio) to receive JBT-101 for the first four weeks at 5
mg once a day (n = 9), 20 mg once a day (n = 9), or 20 mg twice a
day (n = 9) or placebo for the first four weeks, then all JBT-101
subjects received 20 mg twice a day for the next 8 weeks.All
subjects were followed off study drug from weeks 13 through 16.
The primary efficacy objective was to evaluate clinical benefit
in all subjects who received JBT-101 versus subjects who received
placebo using the ACR CRISS score, a measure of improvement in
systemic sclerosis. The CRISS is an exponentially weighted
algorithm of change from baseline that includes the modified
Rodnan skin score (mRSS), a measure of skin thickening, physician
global assessment (MDGA), patient global assessment (PtGA), and
Health Assessment Questionnaire – Disability Index (HAQ-DI), and
forced vital capacity (FVC).
Results:
The median (25th
percentile, 75th
percentile) CRISS scores for the combined JBT-101 group and the
placebo group at Weeks 4, 8, 12, and 16 are provided in the table
below.The difference in CRISS scores between JBT-101 and placebo
groups over the trial period was significant (p = 0.044), 1-sided
mixed model repeated measures using rank transformed data.
|
|
MedianCRISSScore,% (25thpercentile,75thpercentile) |
|||||||
Week4 |
Week8 |
Week12 |
Week16 |
|||||
|
|
3% (0.6%,11.4%) | 19% (0.3%,69.2%) | 27.5% (1.9%,67.8%) | 33% (0.8%,82.1%) | ||||
|
|
1%
|
1%
|
1%
|
0%
|
1) |
Modified intent to treat population, last observation carried forward |
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Results of secondary efficacy outcome measures supported the
finding of clinical benefit of JBT-101, including numerical
superiority of JBT-101 in each of the five domains of the CRISS
score, with divergence starting early at Week 4 or Week 8.
There were no serious, severe, or unexpected adverse events
related to JBT-101. One of 27 subjects (3.7% of subjects) who
received JBT-101 withdrew from the study for an adverse event
which was moderate dizziness.
The primary treatment period has been completed and subjects are
now enrolled in a one- year open label extension to obtain data
on long-term safety and durability of response.The Company
received approval for an open-label extension to its Phase 2
clinical study of JBT-101 for systemic sclerosis from the U.S.
Food and Drug Administration (FDA) in April of 2016. The
open-label extension enables all the participants in the study to
receive JBT-101 for an additional 12 months.
Forward- Looking Statements
This Current Report on Form 8-K contains certain forward-looking
statements within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of
1934 and Private Securities Litigation Reform Act, as amended,
including those relating to the Companys product development,
clinical trials, clinical and regulatory timelines, market
opportunity, competitive position, possible or assumed future
results of operations, business strategies, potential growth
opportunities and other statement that are predictive in nature.
These forward-looking statements are based on current
expectations, estimates, forecasts and projections about the
industry and markets in which we operate and managements current
beliefs and assumptions.
These statements may be identified by the use of forward-looking
expressions, including, but not limited to, expect, anticipate,
intend, plan, believe, estimate, potential, predict, project,
should, would and similar expressions and the negatives of those
terms. These statements relate to future events or our financial
performance and involve known and unknown risks, uncertainties,
and other factors which may cause actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. Such factors include those set forth
in the Companys filings with the Securities and Exchange
Commission. Prospective investors are cautioned not to place
undue reliance on such forward-looking statements, which speak
only as of the date of this press release. The Company undertakes
no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
Item9.01. |
Financial Statements and Exhibits. |
(d) |
Exhibits. |
| Exhibit No. | Description | |
| 99.1 |
Press Release, dated November 14, 2016 by Corbus Pharmaceuticals Holdings, Inc. |
|
| 99.2 | Presentation of Corbus Pharmaceuticals Holdings, Inc. |
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About CORBUS PHARMACEUTICALS HOLDINGS, INC. (CRBP)