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 that the last subject completed their final
visit in the Company’s RESOLVE-1 Phase 3 trial of lenabasum for the
treatment of systemic sclerosis. Topline results from the study are
on track for summer 2020.
“We would like to express our sincere gratitude
to our staff, our clinical collaborators and the study participants
for their commitment and dedication leading to the study completing
on time even in the midst of a global pandemic,” said Yuval Cohen,
Ph.D, Chief Executive Officer.
The RESOLVE-1 Phase 3 trial is a multinational
study evaluating the efficacy and safety of lenabasum in systemic
sclerosis. This was a double-blind, randomized, placebo-controlled
study, with dosing of lenabasum at 20 mg twice per day, or
lenabasum at 5 mg twice per day, or placebo twice per day for 52
weeks, with a 28-day safety follow-up. Study subjects may then
elect to participate in the ongoing open-label extension of
RESOLVE-1.
The primary efficacy endpoint is a composite
score known as the ACR CRISS, measured at Week 52. ACR-CRISS was
also the primary endpoint in the preceding Phase 2 study recently
published in Arthritis & Rheumatology.
Secondary efficacy endpoints include change from
baseline at Week 52 in modified Rodnan skin score, Health
Assessment Questionnaire- Disability index, and forced vital
capacity (FVC) percent predicted. Three hundred and sixty-five
patients were enrolled in the study.
Baseline disease characteristics of subjects in
RESOLVE-1 are similar to those in the Phase 2 study and were
recently presented at American College of Rheumatology (ACR) 2019
Annual Meeting and European League Against Rheumatism (EULAR) 2020
E-Congress.
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)
and Orphan Designation for the treatment of systemic sclerosis from
the European Medicines Agency (EMA).
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 (SSc), a form of scleroderma,
is a chronic, rare, debilitating autoimmune disease affecting
approximately 200,000 people in the North America, EU and Japan.1
Although systemic sclerosis is rare, it is considered one of the
most life-threatening rheumatic diseases.2 Systemic sclerosis
affects the skin and internal organs and is driven by inflammation
and fibrosis (scarring of tissue) leading 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. 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 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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Health Advances, LLC Analysis |
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Bulpitt, Ken J. “Early Undifferentiated Connective Tissue Disease:
III. Outcome and Prognostic Indicators in Early Scleroderma
(Systemic Sclerosis).” Annals of Internal Medicine, vol. 118, no.
8, 15 Apr. 1993, pp. 602–609.,
doi:10.7326/0003-4819-118-8-199304150-00005. |
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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, 20
May 2020,
www.niams.nih.gov/health-topics/scleroderma/advanced#tab-risk. |
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