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 presented additional data from the RESOLVE-1 Phase 3
study of lenabasum for the treatment of systemic sclerosis.
“We are encouraged by the post-hoc analyses
pointing to lenabasum’s therapeutic potential to reduce decline in
lung function in people with systemic sclerosis who have been on
longer-term immunosuppressant drug therapy,” said Yuval Cohen,
Ph.D., Chief Executive Officer of Corbus. “We believe these
findings offer a rationale for additional clinical development of
lenabasum, a non-immunosuppressive agent, that could address lung
function decline in systemic sclerosis patients.”
Summary of findings:
Modified intent-to-treat population (n =
363):
- Stable doses of background
immunosuppressant therapies were allowed in both lenabasum and
placebo arms, reflecting current clinical practice.
- 84% of RESOLVE-1 subjects were on
background immunosuppressant therapies.
- As previously reported, median
American College of Rheumatology Combined Response Index for
Systemic Sclerosis (ACR CRISS) scores at Week 52 were 0.888 versus
0.887, for lenabasum 20 mg twice daily (n = 120) versus placebo (n
= 123).
Placebo group (n = 123):
- Unprecedented improvement was seen
in the placebo group in subjects who were concurrently receiving
stable doses of background immunosuppressant therapies, especially
subjects in their first two years on these therapies.
- Subjects treated with background
mycophenolate had the greatest improvement over the one-year
RESOLVE-1 study.
Post-hoc analyses of lenabasum 20 mg twice daily group
compared to placebo group:
- In subjects receiving established
background immunosuppressant therapies (> 2 years duration at
baseline), lenabasum treatment (n = 38) versus placebo (n = 26) was
associated with reduced decline in forced vital capacity (FVC) at
one year, measured in milliliters (-21 mL versus -170 mL, nominal P
= 0.048) or percent predicted (-0.4% versus -4.6%, nominal P =
0.039).
- Data from these subjects were also
categorized as follows: FVC % decline (worsening by more than -5%),
stable FVC % (values within 5% of baseline value) and improved FVC
% (improvement more than 5%). Lenabasum 20 mg twice daily was
associated with a lower likelihood of a decline (19% lenabasum
versus 50% placebo), greater likelihood to have stable FVC %
predicted (64% lenabasum versus 35% placebo), and similar
likelihood in improvement (17% lenabasum versus 15% placebo,
nominal P = 0.035).
- In a subset of these subjects with
diagnosed interstitial/restrictive lung disease (ILD), lenabasum 20
mg twice daily was associated with numerically reduced decline in
FVC at one year (-14 mL versus -121 mL and -0.3% versus -3.5%),
lenabasum (n = 32) versus placebo (n = 20). ILD was identified by
fibrosis on chest x-ray or computerized tomography of the lungs or
baseline FVC < 80% predicted.
Safety findings:
- Lenabasum was safely administered
and well tolerated in this study, with no new safety findings.
Dizziness (18.3% lenabasum versus 4.9% placebo) and dry mouth (5.0%
lenabasum versus 1.6% placebo) were among adverse events that
occurred in ≥ 3% more subjects in the lenabasum 20 mg twice daily
group versus the placebo group. No evidence of lenabasum-associated
immunosuppression was seen.
The Company is continuing to analyze the data
and will consider the potential for an additional study based on
results of these analyses. Focusing on FVC in patients on
established immunosuppressant therapies could address a key unmet
need, and we believe represent a potential commercial
opportunity.
Lenabasum has been granted Orphan Drug
designation and Fast Track designation for the treatment of
systemic sclerosis from the U.S. Food and Drug Administration
(“FDA”).
Study design:
RESOLVE-1 was a Phase 3 study evaluating the
efficacy and safety of lenabasum in 365 people with diffuse
cutaneous systemic sclerosis on background drug therapy in North
America, Europe, Asia, Israel, and Australia. This was a
double-blind, randomized, placebo-controlled study, with dosing of
lenabasum at 20 mg twice daily, lenabasum at 5 mg twice daily, or
placebo twice daily for 52 weeks. The primary efficacy endpoint was
the median ACR CRISS scores at Week 52. For more information on
RESOLVE-1, please visit ClinicalTrials.gov and reference
Identifier: NCT03398837.
About Lenabasum
Lenabasum is a novel, oral, small molecule
designed to provide an alternative to immunosuppressive treatments
for inflammatory or fibrotic diseases. Lenabasum binds to and
activates the cannabinoid receptor type 2 (CB2), which is
preferentially expressed on activated immune cells, to resolve
inflammation and limit fibrosis. Activity of lenabasum against
inflammation and fibrosis has been demonstrated in animal and human
models of disease. In clinical testing to date, lenabasum has an
acceptable safety profile without evidence of immunosuppression,
has not been associated with laboratory test abnormalities, and has
been well-tolerated.
About Systemic Sclerosis
Systemic sclerosis is a form of the rare disease
scleroderma in which internal organ involvement occurs. Systemic
sclerosis is a chronic, debilitating autoimmune disease that
affects approximately 200,000 people in the North America, EU and
Japan.1 It is considered one of the most life-threatening rheumatic
diseases.2 Disease pathology is characterized by inflammation and
fibrosis (scarring of tissue) which can damage the skin, joints,
tendons, gastrointestinal tract, lungs, heart, kidneys, and small
blood vessels throughout the body.3 There is no cure for systemic
sclerosis, and current treatments address the clinical
manifestations of the disease.4
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 designed to provide an alternative to
immunosuppressive medications in the treatment of chronic
inflammatory and fibrotic diseases. 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
- Health Advances, LLC Analysis
-
Elhai M, Meune C, Avouac J, Kahan A, Allanore Y. Trends in
mortality in patients with systemic sclerosis over 40 years: a
systematic review and meta-analysis of cohort studies. Rheumatology
2012;51(6):1017e26
-
Sierra-Sepulveda A, Esquinca-Gonzalez A, Benavides-Suarez SA,
Sordo-Lima DE, Caballero-Islas AE, Cabral-Castaneda AR, et al.
Systemic Sclerosis Pathogenesis and Emerging Therapies, beyond the
Fibroblast. Biomed Res Int. 2019;2019:4569826
-
Scleroderma. National Institute of Arthritis and Musculoskeletal
and Skin Diseases, U.S. Department of Health and Human Services, 5
November 2020,
www.niams.nih.gov/health-topics/scleroderma/advanced#tab-risk.
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