Corbus Announces Publication of Lenabasum Systemic Sclerosis Double-Blind, Placebo-Control Phase 2 Clinical Trial Results in ...
April 29 2020 - 8:05AM
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or
the “Company”), a clinical-stage drug development company
pioneering transformative medicines that target the endocannabinoid
system (ECS), today announced the publication of results from the
double-blind, randomized, placebo-controlled Phase 2 trial
assessing the safety and efficacy of lenabasum in 42 patients with
diffuse cutaneous systemic sclerosis in Arthritis &
Rheumatology. The paper [doi:10.1002/art.41294] is titled “Safety
and efficacy of lenabasum in a Phase 2 randomized,
placebo-controlled trial in adults with systemic sclerosis.” As
previously reported, data showed treatment with lenabasum was
associated with improvements across the primary endpoint, the
American College of Rheumatology Combined Response Index in diffuse
cutaneous Systemic Sclerosis (ACR CRISS) score and multiple
secondary efficacy outcomes. The study results also demonstrated
that lenabasum has an acceptable safety profile.
Efficacy and safety of lenabasum in systemic
sclerosis are currently being evaluated in Corbus’ global,
365-subject, RESOLVE-1 Phase 3 study. Baseline characteristics of
subjects are similar to those in the Phase 2 study. RESOLVE-1 has
enrolled 365 individuals with SSc in an international, multicenter,
randomized, double-blind, placebo-controlled study. The primary
efficacy endpoint is ACR CRISS score. The study is also evaluating
multiple secondary endpoints, including changes in HAQ-DI, mRSS and
FVC percent predicted.
Topline data from the RESOLVE-1 study remain on track for summer
2020.
About LenabasumLenabasum is a
rationally designed, oral, small molecule that selectively binds as
an agonist to the cannabinoid receptor type 2 (CB2) and has been
designed to resolve inflammation, limit fibrosis and support tissue
repair. 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. Additional clinical studies are
being conducted to confirm these results and support applications
for regulatory approval.
About CorbusCorbus
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. Corbus expects data from its
Phase 1 safety study in 2020.
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 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,
including 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 Tartaglia Stern Investor RelationsPhone: +1 (212)
362-1200Email: christina@sternir.com
Corbus Pharmaceuticals (NASDAQ:CRBP)
Historical Stock Chart
From May 2024 to Jun 2024
Corbus Pharmaceuticals (NASDAQ:CRBP)
Historical Stock Chart
From Jun 2023 to Jun 2024