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 the final
visit in the double-blind, placebo-controlled part of the Company’s
Phase 3
DETER
MINE study of
lenabasum for the treatment of dermatomyositis. The open-label
extension of the study is ongoing. Topline results from the study
are on track to be reported in the second quarter of 2021.
The Phase 3 trial is an international,
176-subject study evaluating the safety and efficacy of lenabasum
in adult dermatomyositis patients who are receiving standard
treatments, including background immunosuppressive therapies. This
study is the largest randomized, double-blind, placebo-controlled
dermatomyositis study to date. Subjects were randomized 2:1:2 to
either receive lenabasum 20 mg twice per day, lenabasum 5 mg twice
per day, or placebo twice per day.
The primary efficacy endpoint is the composite
American College of Rheumatology/European League Against Rheumatism
2016 Total Improvement Score (“Total Improvement Score”) at Week
28. Change from baseline will be provided for each component of the
Total Improvement Score to support this composite endpoint.
Definition of Improvement, Investigator Global Assessment scale of
skin activity, and Cutaneous Dermatomyositis Activity and Severity
Index activity score are among secondary efficacy endpoints.
Lenabasum was granted Orphan Drug Designation
for the treatment of dermatomyositis from the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA).
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. Data from animal models and human
clinical studies suggest that lenabasum can reduce expression of
genes and proteins involved in inflammation and fibrosis. In
clinical testing to date, lenabasum has an acceptable safety and
tolerability profiles without evidence of immunosuppression.
About Dermatomyositis
Dermatomyositis (DM), a form of myositis, is a
chronic, rare, inflammatory, clinically heterogenous,
life-threatening autoimmune disease affecting approximately 80,000
people in North America, EU and Japan.1 The signs and symptoms of
DM reflect multi-organ involvement, which includes distinctive skin
rashes usually accompanied by proximal muscle weakness, and can
also include pulmonary, cardiac, gastrointestinal, and joint
involvement.2 Patients with DM can have recurrent disease flares or
chronic progressive disease activity, with increased mortality.3,4
The current mainstay of treatments include FDA-approved systemic
glucocorticoids, adrenocorticotropic hormone analogue and off-label
use of glucocorticoid-sparing immunosuppressive agents.5,6 There is
significant unmet need for new treatments to achieve disease
control in DM because of limited efficacy or toxicity of
immunosuppressive agents or refractory disease.7,8
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 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
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
- Health Advances, LLC Analysis
- “Dermatomyositis Information Page.” National Institute of
Neurological Disorders and Stroke, U.S. Department of Health and
Human Services, 26 March 2021,
www.ninds.nih.gov/Disorders/All-Disorders/Dermatomyositis-Information-Page
- Marie, Isabelle. “Morbidity and Mortality in Adult Polymyositis
and Dermatomyositis.” Current Rheumatology Reports, vol. 14, no. 3,
2012, pp. 275–285., doi:10.1007/s11926-012-0249-3
- Schiopu, Elena, et al. “Predictors of Survival in a Cohort of
Patients with Polymyositis and Dermatomyositis: Effect of
Corticosteroids, Methotrexate and Azathioprine.” Arthritis Research
& Therapy, vol. 14, no. 1, 2012, doi:10.1186/ar3704
- FDA label Orapred ODT, availableat
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021959s004lbl.pdf;
accessed 26 March 2021
- FDA label H.P. Acthar gel, available at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008372s057lbl.pdf;
accessed 26 March 2021
- Dalakas, Marinos C. “Immunotherapy of Myositis: Issues,
Concerns and Future Prospects.” Nature Reviews Rheumatology, vol.
6, no. 3, Mar. 2010, pp. 129–137., doi:10.1038/nrrheum.2010.2
- DeWane ME, et al. Dermatomyositis: Clinical features and
pathogenesis. J Am Acad Dermatol.
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