CORBUS PHARMACEUTICALS HOLDINGS, INC. (NASDAQ:CRBP) Files An 8-K Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
On March 30, 2017, Corbus Pharmaceuticals Holdings, Inc. (the
Company) announced that it was hosting a conference call to
provide an update on the Companys Phase 2 cystic fibrosis
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.
Item 8.01. Other Events
On March 30, 2017, the Company announced positive topline data
from its Phase 2 study evaluating multiple doses of anabasum (fka
JBT-101 or Resunab) compared to placebo for the treatment of
patients with cystic fibrosis (CF). The 16-week study dosed 85
adult CF patients with baseline forced expiratory volume in 1
second (FEV1) percent predicted 40%, who were enrolled without
regard to their specific CFTR mutation or infecting pathogens and
continued with all baseline treatment regimens.
Anabasum successfully achieved the primary objective of the study
by demonstrating an acceptable safety and tolerability profile at
all doses with no serious or severe adverse events related to the
study drug.
Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the
non-profit drug discovery and development affiliate of the Cystic
Fibrosis Foundation, supported the Phase 2 study.
Anabasum cohorts showed a dose-dependent reduction in a number of
acute pulmonary exacerbations defined as those requiring
intravenous (IV) antibiotics compared to placebo. Patients in the
highest dose cohort of anabasum (20 mg orally, twice per day) had
a 75% reduction in the annualized rate of pulmonary exacerbations
requiring IV antibiotics compared to placebo cohort.
Additionally, anabasum caused a consistent reduction in multiple
inflammatory cell types in sputum, including total leukocytes,
neutrophils, eosinophils, and macrophages. Inflammatory
mediators, including interleukin-8, neutrophil elastase, and
immunoglobulin G, were also reduced in sputum by anabasum in a
dose-dependent manner. These patient data provide evidence of
biological activity of anabasum in resolving ongoing innate
immune responses in lungs of CF patients and support the observed
reduction in pulmonary exacerbations.
Serum concentrations of orally-administered anabasum in CF
patients were similar to those previously observed in healthy
volunteers. FEV1 remained stable throughout the duration of the
study in all treatment cohorts.
Study Design and Results
This was an international, multi-center, double-blinded,
randomized, placebo-controlled Phase 2 study supported in part by
a $5 million Development Award from Cystic Fibrosis Foundation
Therapeutics, Inc. The primary objective of the study was to test
safety and tolerability of anabasum in adults with CF who had
FEV1 40 percent predicted and remained on background CF
medications, including prophylactic antibiotics. Patients were
enrolled without regard to their CFTR mutation, infecting
pathogen, or baseline treatment. Acute pulmonary exacerbations
requiring IV antibiotic treatment were captured as an event of
special interest during the study. Secondary objectives included
measurement of plasma concentrations and metabolites of anabasum
and change from baseline in FEV1 percent predicted and Cystic
Fibrosis Questionnaire-Revised Respiratory Symptom score.
Additional outcomes included change from baseline in sputum and
blood biomarkers of inflammation.
Eighty-five patients on stable standard-of-care medications were
dosed with anabasum or placebo at 21 sites in the U.S. and Europe
and treated for 84 days, with a follow-up period of 28 days off
treatment. During the first part of the study (Weeks 1-4)
patients were randomized to placebo (n = 35), 1 mg/day anabasum
(n = 26) or 5 mg/day anabasum (n = 24). During the second part of
the study (Weeks 5-12), anabasum patients were randomly assigned
to anabasum 20 mg once per day (n = 31) or anabasum 20 mg twice
per day (n = 30) with 11 patients from the placebo cohort
randomly assigned to the 2 anabasum cohorts. Twenty-four patients
continued to receive placebo in Weeks 5-12.
After dosing, 10 patients discontinued early from the study; 3
patients withdrew consent, 5 withdrew due to adverse events (2 on
placebo, 3 on anabasum), 1 subject was lost to follow-up and 2
patients withdrew for treatment-unrelated reasons. Baseline
characteristics were similar between anabasum and placebo
cohorts.
Safety
During Weeks 1-4, treatment-emergent adverse events (TEAEs)
occurred in 14 (54%) of patients in the anabasum 1 mg cohort, 13
(54%) of the anabasum 5 mg cohort and 15 (43%) of the placebo
cohort. During Weeks 5-12, TEAEs occurred in 21 (68%) patients in
the anabasum 20 mg once per day cohort, 19 (63%) of the anabasum
20 mg twice per day cohort and 14 (58%) of the placebo cohort.
Six serious adverse events (SAEs) occurred the anabasum-treated
patients and 6 SAEs occurred in placebo-treated patients. Three
severe TEAEs occurred in the anabasum-treated patients and 4 in
placebo-treated patients. None of the serious or severe TEAEs
were assessed by site investigators to be related to study drug.
The most common drug-related adverse event that occurred in more
than 2 individuals was mild dry mouth observed in 8 (13%) of
anabasum patients and no placebo patients. As expected, the
respiratory system was the most common source of TEAEs overall.
Cmax values for anabasum were similar to those previously
measured in healthy human volunteers after similar doses of
anabasum.
Acute Pulmonary Exacerbations
Treatment with anabasum yielded a dose-dependent reduction in
acute pulmonary exacerbations. The highest dose of anabasum (20
mg twice per day) was associated with a 75% reduction in the
annualized rate of pulmonary exacerbations requiring treatment
with IV antibiotics, compared to placebo. Similar levels of
reduction were also observed in acute pulmonary exacerbations
defined by new or worsening respiratory symptoms requiring
treatment with any antibiotic.
Inflammatory Cells and Biomarkers
Patients treated with anabasum 20 mg twice a day showed a
consistent reduction in multiple inflammatory cell types in their
sputum at the end of active treatment compared to placebo,
including total leukocytes, neutrophils, eosinophils, lymphocytes
and macrophages. They also had a consistent reduction in
inflammatory mediators in their sputum including interleukin-8,
neutrophil elastase and immunoglobulin G.
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.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
| Exhibit No. | Description | |
| 99.1 |
Press Release, dated March 30, 2017 by Corbus Pharmaceuticals Holdings, Inc. |
|
| 99.2 | Presentation of Corbus Pharmaceuticals Holdings, Inc. | |
|
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About CORBUS PHARMACEUTICALS HOLDINGS, INC. (NASDAQ:CRBP)
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage pharmaceutical company. The Company is focused on the development and commercialization of therapeutics to treat rare or uncommon chronic and serious inflammatory and fibrotic diseases. The Company’s segment is developing and commercializing therapeutics to treat rare life-threatening inflammatory fibrotic diseases. Its product, Resunab, is a synthetic oral endocannabinoid-mimetic drug that is designed to resolve chronic inflammation and halt fibrotic processes without causing immunosuppression. Resunab is being evaluated in approximately three separate Phase II studies for the treatment of cystic fibrosis, systemic sclerosis and skin-predominant dermatomyositis. The United States Food and Drug Administration has granted Resunab Orphan Drug Designation, as well as Fast Track Status, for both cystic fibrosis and systemic sclerosis. Resunab is in Phase II clinical stage for the treatment of Systemic Lupus Erythematosus. CORBUS PHARMACEUTICALS HOLDINGS, INC. (NASDAQ:CRBP) Recent Trading Information
CORBUS PHARMACEUTICALS HOLDINGS, INC. (NASDAQ:CRBP) closed its last trading session 00.00 at 9.00 with 865,890 shares trading hands.