Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or
the “Company”), a clinical-stage drug development company
pioneering transformative medicines that target the endocannabinoid
system, today announced the presentation of the preliminary data
from its 28 week Phase 2b study of lenabasum in patients with
cystic fibrosis (CF) at the North American Cystic Fibrosis
Conference (NACFC) held online, Oct 7-23, 2020. The data are being
presented in poster number 817 titled: “CB2 Agonist, Lenabasum, for
the Treatment of Pulmonary Exacerbations in Cystic Fibrosis.” These
data can be found at the following link: NACFC Poster #817
James Chmiel, M.D., MPH, Principal Investigator
of CF-002 and Division Chief for Pediatric Pulmonology, Allergy and
Sleep Medicine and Professor of Pediatrics at Indiana University
School of Medicine said, “This was the first interventional study
in CF to select for patients who have high rates of pulmonary
exacerbations and one of the largest CF studies to date. The
negative impact of recurrent pulmonary exacerbations on the health
and quality of life of people with CF cannot be overstated, nor can
the need to find non-immunosuppressive treatments to control the
lung inflammation that causes these events.” Dr. Chmiel commented
further, “While I am disappointed that the study did not achieve
its primary endpoint, I am encouraged by findings of potential
reduction in exacerbation rates in subjects with similar lung
function and treatment with CFTR-modulators. I look forward to
further analyses of the data, because they may confirm the initial
clinical rationale to continue development of lenabasum for
treatment of pulmonary exacerbations in people with CF.”
Summary of findings:
- Disposition, baseline demographics,
and baseline disease characteristics and treatments were as
expected (Tables 1 and 2 as presented in the poster). Enrolled
subjects had significantly impaired mean baseline FEV1 and between
2-7 PEx in the prior year, despite background treatments reported
to reduce PEx rates.
- Lenabasum did not meet its primary
efficacy endpoint of reducing the rate of PEx. PEx rates per
subject per 28 weeks were as follows: 0.85, 0.75 and 0.90 for
placebo, 5 mg, and 20 mg doses, respectively (Table 3).
- Mean baseline FEV1 % predicted was
similar across treatment groups, approximately 60% predicted. No
significant differences among treatment groups were seen in change
in FEV1% predicted (Table 4).
- Lenabasum was safely administered
and well tolerated in this study, with no new safety findings.
Dizziness, fatigue, and dry mouth were among adverse events that
occurred in ≥ 2% of subjects in the lenabasum group versus the
placebo group (Tables 5 and 6).
- Exploratory post-hoc analyses of
the placebo group revealed that subjects from 5 eastern European
countries (accounting for 21% of study participants) had PEx rates
that were about 85% lower than in subjects from other countries
(shown for placebo group in Table 7).
- Exploratory post-hoc analyses of
the placebo group excluding subjects from these 5 countries also
showed differences in PEx rates among subjects with different
baseline disease characteristics or background treatments (Table
8).
- Exploratory post-hoc analyses,
excluding subjects from these 5 countries, are presented for
subjects with more severe baseline airways obstruction (FEV1 ≥ 40%
to < 70% predicted) and those with less severe airways
obstruction at baseline (FEV1 ≥ 70% to < 90% predicted). These
groups were further separated into subjects receiving
CFTR-modulating drugs and those who did not. Lenabasum was
associated with a reduction in PEx rates in a number of these
subsets where the magnitude of change ranged from 27% - 61% (Table
9).
Study design
CF-002 was a multinational Phase 2b study
evaluating the efficacy and safety of lenabasum in CF. This was a
double-blind, randomized, placebo-controlled study, with dosing of
lenabasum at 5 mg twice per day, lenabasum 20 mg twice per day or
placebo twice per day for 28 weeks, with 4 weeks safety follow-up
off active treatment. The primary efficacy endpoint was the event
rate of new PEx per subject per 28 weeks, when the primary
definition of new PEx was physician diagnosis of PEx, prescription
of new antibiotics for that PEx starting more than 28 days after
completion of the last antibiotic course for any previous PEx, with
4 out of 12 Fuch’s criteria present in the subject. The Phase 2b CF
study was funded in part by a Therapeutic Development Award for up
to $25 Million from the Cystic Fibrosis Foundation.
For more information on the Phase 2b study of
lenabasum for the treatment of Cystic Fibrosis, please visit
ClinicalTrials.gov and reference Identifier: NCT03451045
About Lenabasum
Lenabasum is a novel, oral, small molecule that
selectively binds as an agonist to the cannabinoid receptor type 2
(CB2) and resolves inflammation and limits fibrosis in animal and
human models of disease. CB2 is preferentially expressed on
activated immune cells and on fibroblasts, muscle cells, and
endothelial cells. Lenabasum has demonstrated acceptable safety and
tolerability profiles and has not been immunosuppressive in
clinical studies to date.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a
clinical-stage company focused on the development and
commercialization of novel medicines designed to target the
endocannabinoid system. The Company’s lead product candidate,
lenabasum, is a novel, oral, selective cannabinoid receptor type 2
(CB2) agonist that resolves chronic inflammation and limits
fibrosis in animal and human models. Lenabasum is currently being
evaluated in dermatomyositis and systemic lupus erythematosus.
Corbus is also developing a pipeline of other preclinical drug
candidates from its endocannabinoid system platform.
Lenabasum is not approved for the treatment of
any indication. For more information on Corbus’ clinical programs,
please visit here.
For more information, visit
http://www.corbuspharma.com/, and connect with us on Twitter,
LinkedIn, and Facebook.
Forward-Looking Statements
This press release 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 Company's restructuring,
trial results, product development, 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 management's
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,
including the potential impact of the recent COVID-19 pandemic and
the potential impact of sustained social distancing efforts, on our
operations, clinical development plans and timelines, 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 Company's 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.
Corbus Pharmaceuticals Contacts:
Ted Jenkins, Senior Director, Investor Relations and Corporate
CommunicationsPhone: +1 (617) 415-7745Email:
ir@corbuspharma.com
Lindsey Smith, Director, Investor Relations and Corporate
CommunicationsPhone: +1 (617) 415-7749Email:
mediainfo@corbuspharma.com
Christina TartagliaStern Investor RelationsPhone: +1 (212)
362-1200Email: christina.tartaglia@sternir.com
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