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 topline results from the 52-week Phase 3
RESOLVE-1 study of lenabasum in patients with diffuse cutaneous
systemic sclerosis (SSc). SSc is a rare and life-threatening
multi-system autoimmune disease for which there are currently no
U.S. Food and Drug Administration (FDA)-approved treatments for
overall disease.
Topline data showed no significant differences
in the primary and secondary endpoints when comparing lenabasum to
placebo, both added to background drug therapy.
For the primary endpoint, the median American
College of Rheumatology Combined Response Index for Systemic
Sclerosis (ACR CRISS) scores at Week 52 were 0.887 in the placebo
arm and 0.888 in the lenabasum 20 mg twice daily arm. ACR CRISS is
a composite endpoint that reflects the probability of patient
improvement. The maximum achievable ACR CRISS score is 1.0.
RESOLVE-1 is the first 52-week, randomized,
placebo-controlled Phase 3 trial that tested the efficacy and
safety of lenabasum in 365 patients with diffuse cutaneous SSc in a
multinational, 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 majority of
enrolled patients (84%) were receiving background immunosuppressive
drugs, reflecting recent trends in clinical practice.
Similar proportions of placebo-treated and
lenabasum-treated subjects had at least one treatment emergent
adverse event (AEs), 86.2% in the placebo arm and 91.7% in the
lenabasum 20 mg twice daily arm. Serious AEs occurred in 14.6% of
subjects in the control arm and 9.2% of subjects in the lenabasum
20 mg twice daily arm. Severe AEs occurred in 13% of subjects in
the control arm and 5.8% of subjects in the lenabasum arm. No
subjects receiving lenabasum withdrew from the study because of an
AE-related to study drug. Lenabasum treatment was well-tolerated in
this study. No evidence of lenabasum-related immunosuppression or
new safety signals for lenabasum were observed.
Further analyses of these data are underway, and
once Corbus has a fuller understanding of the data, the Company
would like to engage with the FDA to determine potential next steps
in this clinical development program. The data will be presented at
upcoming medical conferences.
Yuval Cohen, Ph.D., Chief Executive Officer of
Corbus said, “We are surprised and deeply disappointed that the
RESOLVE-1 trial did not meet its primary endpoint. I would like to
extend my gratitude to the participants in the study and the
clinical staff at the study sites, as well as to the Corbus
employees, for their hard work and dedication. We now look forward
to upcoming topline results from our study of lenabasum in patients
with cystic fibrosis.”
Robert Spiera, M.D., Co-Principal
Investigator on RESOLVE-1 and Director of the Scleroderma,
Vasculitis, and Myositis Program at the Hospital for Special
Surgery, Weill Cornell Medical College in New York City said, “I am
genuinely surprised by these results. Immunosuppressive drugs,
alone or in combination, are increasingly becoming a mainstay of
treatment for patients with early diffuse cutaneous SSc. However,
the impact of these drugs on disease has not previously been
studied systematically and clearly was underappreciated by the
community of SSc experts. The high degree of efficacy of background
drug therapy in the control arm is well beyond what was
expected.”
Professor Christopher Denton, PhD, FRCP,
Co-Principal Investigator on RESOLVE-1 and Professor of
Experimental Rheumatology at UCL Medical School and Consultant
Rheumatologist and Joint Director of the Centre for Rheumatology,
Royal Free Hospital, London said, “Whilst the immediate study
results are disappointing, RESOLVE-1 provides a rich dataset to
understand for the first time how to better target treatments for
SSc based upon clinical parameters and concomitant treatment. We
are already querying the data to understand the natural history of
early diffuse cutaneous SSc and the potential benefits of lenabasum
in these subjects. Despite the efficacy of current
immunosuppressive treatments in early diffuse cutaneous systemic
sclerosis, there is still major unmet need in this patient group.
The potential value of a non-immunosuppressive treatment, added-to
or used instead of, additional immunosuppressive medications,
remains exciting. The safety profile and tolerability of lenabasum
is very attractive for use in SSc patients.”
Barbara White, M.D., Chief Medical Officer and
Head of Research of Corbus commented, “We will now focus on further
analyses of the data to potentially identify groups of patients
that may have responded to lenabasum.”
Lenabasum was granted Orphan Drug designation
and Fast Track designation for the treatment of SSc from the FDA
and Orphan Designation for the treatment of SSc from the European
Medicines Agency.
Lenabasum is currently being evaluated in a
Phase 3 DETERMINE study in
dermatomyositis, a Phase 2 study in systemic lupus erythematosus,
and a Phase 2b study in cystic fibrosis.
RESOLVE-1 Phase 3 Study Trial Design
The RESOLVE-1 Phase 3 trial tested the efficacy
and safety of lenabasum in people with diffuse cutaneous SSc 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.
Three hundred and sixty-five patients were dosed
in the study. Baseline characteristics of patients across groups
were balanced.
The primary efficacy outcome for the Phase 3
RESOLVE-1 is a composite clinical trial endpoint known as the ACR
CRISS score, assessed at Week 52. The ACR CRISS score was also the
primary efficacy endpoint in the preceding Phase 2 study published
in Arthritis & Rheumatology in April 2020. The ACR CRISS score
is a composite clinical trial endpoint that assesses probability
that the subject has improved from baseline and integrates change
from baseline in five endpoints selected by experts to be the most
relevant indicators of disease improvement in diffuse cutaneous
SSc. Secondary efficacy endpoints include three of the five core
items of ACR CRISS assessed as change from baseline at Week 52 in
mRSS, Health Assessment Questionnaire-Disability index (HAQ-DI),
and forced vital capacity (FVC) percent predicted.
Conference Call details
Management will host a conference call and
webcast presentation today, Tuesday, September 8th, 2020 at 8:30
a.m. ET.
To participate in the call, please dial (877)
407-3978 (domestic) or (412) 902-0039 (international). The live
webcast will be accessible on the Events page of the investors
section of the Corbus website, www.corbuspharma.com, and will be
archived for 90 days.
About Lenabasum
Lenabasum is a rationally designed, oral, small
molecule that selectively binds as an agonist to the cannabinoid
receptor type 2 (CB2), resolves inflammation, and limits fibrosis.
CB2 is preferentially expressed on activated immune cells and on
fibroblasts, muscle cells, and endothelial cells. In both animal
and human studies conducted to date, lenabasum has induced the
production of pro-resolving lipid mediators that activate
endogenous pathways which resolve inflammation and speed bacterial
clearance without immunosuppression. Data from animal models and
human clinical studies suggest that lenabasum can reduce expression
of genes and proteins involved in inflammation and fibrosis.
Lenabasum has demonstrated promising activity in animal models of
skin and lung inflammation and fibrosis in systemic sclerosis
(SSc). Lenabasum is also active in animal models of lung infection
and inflammation in cystic fibrosis and joint inflammation and
scarring in rheumatoid arthritis.
Lenabasum has demonstrated acceptable safety and
tolerability profiles in clinical studies to date. Lenabasum
treatment was associated with improvement in multiple
physician-assessed and patient-reported efficacy outcomes in Phase
2 studies in patients with diffuse cutaneous SSc and patients with
dermatomyositis with active skin involvement but not currently
active muscle involvement. Lenabasum treatment also was associated
with a lower rate of and longer time to pulmonary exacerbations in
a Phase 2 cystic fibrosis study.
Lenabasum is not approved for the treatment of
systemic sclerosis, dermatomyositis, cystic fibrosis or systemic
lupus erythematosus.
About Systemic Sclerosis
Systemic sclerosis, a form of scleroderma, is a
chronic, rare, debilitating autoimmune disease affecting
approximately 200,000 people in the North America, EU and
Japan.1 Systemic sclerosis is considered one of the most
life-threatening rheumatic diseases.2 The disease affects
affects the skin and internal organs and is driven by inflammation
and fibrosis (scarring of tissue) which can lead to severe damage
and failure of multiple organs including the skin, joints, tendons,
gastrointestinal tract, lungs, heart, blood vessels and
kidneys.3 There is no cure for systemic sclerosis, and current
treatments address the clinical manifestations of the disease, not
the underlying mechanisms that drive inflammation and
fibrosis.4
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a Phase
3 clinical-stage pharmaceutical company focused on the development
and commercialization of novel therapeutics to treat inflammatory
and fibrotic diseases by leveraging its pipeline of rationally
designed, endocannabinoid system-targeting drug candidates. The
Company’s lead product candidate, lenabasum, is a novel, oral,
selective cannabinoid receptor type 2 (CB2) agonist rationally
designed to resolve chronic inflammation and fibrotic processes.
Lenabasum is currently being evaluated in systemic sclerosis,
cystic fibrosis, dermatomyositis and systemic lupus
erythematosus.
Corbus is also developing a pipeline of drug
candidates targeting the endocannabinoid system. The pipeline
includes CRB-4001, a 2nd generation, selective cannabinoid receptor
type 1 (CB1) inverse agonist designed to be peripherally
restricted. Potential indications for CRB-4001 include nonalcoholic
steatohepatitis (NASH), among others.
Lenabasum is not approved for the treatment of
systemic sclerosis, dermatomyositis, cystic fibrosis or systemic
lupus erythematosus. CRB-4001 is not approved for the treatment of
NASH/NAFLD. For more information on Corbus’ clinical programs,
please visit here.
Please visit www.CorbusPharma.com and connect
with the Company 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 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
Communications Phone: +1 (617) 415-7745
Email: ir@corbuspharma.com
Lindsey Smith, Director, Investor Relations and Corporate
Communications Phone: +1 (617) 415-7749
Email: mediainfo@corbuspharma.com
Christina Tartaglia Stern Investor Relations Phone: +1 (212)
362-1200 Email: christina.tartaglia@sternir.com
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2012;51(6):1017e26 |
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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 |
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Scleroderma.” National Institute of Arthritis and Musculoskeletal
and Skin Diseases, U.S. Department of Health and Human Services, 7
September 2020,
www.niams.nih.gov/health-topics/scleroderma/advanced#tab-risk. |
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