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 completion of subject enrollment in
DETER
MINE, a Phase 3 study
assessing the efficacy and safety of lenabasum for the treatment of
dermatomyositis (“DM”). The Company expects to report topline
results from this study in the fourth quarter of 2021.
“We are grateful to the participants for their
commitment and to all of our investigators and their staff for
their support of the study and dedication to completing enrollment
on time, despite COVID-19,” said Barbara White, M.D., Chief Medical
Officer of Corbus. “Enrollment exceeded our expectations, which we
think speaks to the unmet need of dermatomyositis patients for new
treatment options, especially options without some of the
toxicities associated with chronic immunosuppression.”
The Company’s Phase 3
DETERMINE study has enrolled 176
subjects in the largest, randomized, double-blind,
placebo-controlled DM study to date. This study is being conducted
in North America, Europe, and Asia. Patients in the study are
randomized 2:1:2 to either receive lenabasum 20 mg twice per day,
lenabasum 5 mg twice per day or placebo twice per day for 52 weeks
with a follow-up period of 4 weeks.
The primary endpoint of
DETERMINE is efficacy of
lenabasum compared to placebo as measured by the American College
of Rheumatology (“ACR”)/ European League Against Rheumatism 2016
Total Improvement Score (“TIS”) in myositis at 52 weeks, a weighted
composite measure of improvement from baseline in six core set
items that include physician directed assessments of Physician
Global Activity, Manual Muscle Testing-8, and Extramuscular Global
Activity, patient-reported outcomes of Patient Global Activity and
Health Assessment Questionnaire, and biomarkers of muscle enzymes.ǂ
Multiple secondary outcomes including Cutaneous Dermatomyositis
Activity and Severity Index activity score are being evaluated.
Additionally, the Company is evaluating the safety and efficacy of
lenabasum in an open-label extension of the
DETERMINE Phase 3 study. The
open-label extension enables participants who complete the
double-blind study period to continue to receive lenabasum.
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 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 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 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
ǂAggarwal R, et al. “2016 American College of
Rheumatology/European League Against Rheumatism criteria for
minimal, moderate, and major clinical response in adult
dermatomyositis and polymyositis: An International Myositis
Assessment and Clinical Studies Group/Paediatric Rheumatology
International Trials Organisation Collaborative Initiative.” Ann
Rheum Dis. 2017 May ; 76(5): 792–801
1. Health Advances, LLC Analysis
- “Dermatomyositis
Information Page.” National Institute of Neurological Disorders and
Stroke, U.S. Department of Health and Human Services, 15 June 2020,
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, available at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021959s004lbl.pdf;
accessed 15 June 2020
- FDA label H.P. Acthar gel, available at
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008372s057lbl.pdf;
accessed 15 June 2020
- 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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