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 3 abstracts at the 6th
Systemic Sclerosis World E-Congress. The data presented in these
abstracts show that the American College of Rheumatology Combined
Response Index in diffuse cutaneous Systemic Sclerosis (ACR CRISS)
score positively correlates with improvements in multiple
patient-reported outcomes. Importantly, the ACR CRISS score also
correlates more strongly with these patient-reported outcomes than
change in modified Rodnan Skin Score (mRSS). Together, these data
show that the ACR CRISS score broadly reflects changes from
baseline in how patients feel and function. These data will be
presented in a recorded oral presentation and two e-posters at the
6th Systemic Sclerosis World E-Congress on June 29, 2020. Two live
discussions sessions for the oral presentation will be held during
the Live Congress on July 12, 2020 at 16:00-16:30 UCT+2 (Rome,
Italy) time and on July 13, 2020 at 11:30-12:00 UCT+2 (Rome, Italy)
time. All three abstracts will be published in the Journal of
Scleroderma and Related Disorders. In addition, the Company
announced it will sponsor a satellite symposium titled “The Role of
the Endocannabinoid System in Chronic Inflammation and Fibrosis”
hosted by Professor Christopher Denton, MB, BS, PhD, FRCP, Head of
Centre and Consultant Rheumatologist, University College London
Division of Medicine, and Tracy Frech, M.D., MS, Director of the
Systemic Sclerosis Clinic at the University of Utah Hospital and
the Director of Clinical Trials for the Division of Rheumatology.
The symposium will be held at the Live Congress on Sunday, July 12,
2020 at 14:30 UCT+2 (Rome, Italy) time. Once the presentation is
made public, it will be available along with the three abstracts on
the Company’s website in the Scientific Conferences section.
“These findings clearly demonstrate that ACR
CRISS score reflects improvement in multiple measures of how SSc
patients feel and function. This may be because the ACR CRISS score
itself, unlike change in mRSS, incorporates 2 key patient-reported
outcomes, the Health Assessment Questionnaire-Disability Index and
the Patient Global Assessment of Health related to SSc. Our results
support usefulness of using ACR CRISS score to evaluate clinical
burden and benefit to patients in SSc trials,” said Barbara White,
M.D., Chief Medical Officer and Head of Research of Corbus. “We
remain on track to announce topline Phase 3 results using ACR CRISS
score as the primary efficacy outcome later this summer.”
Oral Presentation
In a recorded oral presentation, Robert Spiera,
M.D., Director of the Vasculitis and Scleroderma Program at the
Hospital for Special Surgery, will present findings from Abstract
120: Provisional American College of Rheumatology (ACR) Combined
Response Index in diffuse cutaneous Systemic Sclerosis (CRISS)
Score Correlates with Changes in Patient-reported Outcomes (PROs).
The presentation is available in the Scientific Conferences section
of Corbus’ website.
Poster Presentations
Similarly, e-poster presentations, Poster 158:
Health Assessment Questionnaire Disability Index (HAQ-DI) and
Patient Global Assessment of Health (PtGA) Correlate with Changes
in Patient Reported Outcomes (PROs) and Poster 159: Patient and
Physician Opinion of Clinical Benefit at 3 Months in a Clinical
Trial Correlate with Patient Reported Outcomes (PROs) will be
presented. The posters are available in the Scientific Conferences
section of Corbus’ website.
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 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) 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. 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
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.tartaglia@sternir.com
- Health Advances, LLC Analysis
- 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.
- 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, 8 June 2020,
www.niams.nih.gov/health-topics/scleroderma/advanced#tab-risk.
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