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 participant was enrolled in a
Phase 2 study of lenabasum for the treatment of systemic lupus
erythematosus (SLE).
The 16-week, U.S., multi-center,
first-in-patient, exploratory clinical trial enrolled 101
participants to evaluate the safety, efficacy, and tolerability of
lenabasum in adults with SLE who are receiving standard treatments,
including background immunosuppressive therapies. This study is the
first randomized, double-blind, placebo-controlled study targeting
the potential role of the cannabinoid receptor type 2 in SLE.
Patients in the study are randomized 1:1:1:1 to either receive
lenabasum 20 mg twice daily, lenabasum 20 mg once daily, lenabasum
5 mg twice daily, or placebo.
The primary efficacy endpoint is change from
baseline in the 7-day average of the maximum daily Numerical Rating
Scale-Pain score at Week 12. Secondary efficacy assessments include
other evaluations of musculoskeletal pain and disease activity, SLE
Responder Index, SELENA-SLEDAI score, BILAG-2004 score, Physician
Global Assessment, Lupus Activity Patient Global Assessment, and
PROMISE-29 scores. Various biomarkers will also be measured.
The clinical trial (ClinicalTrials.gov
identifier: NCT03093402) is led by principal investigator, Meggan
Mackay, M.D., professor at the Feinstein Institutes for Medical
Research, and is sponsored and funded
(UM1AI110494) by the National Institute of Allergy
and Infectious Diseases, part of the National Institutes of Health
(NIH). Topline results from the study are expected in the second
half of 2021.
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 acceptable safety and
tolerability profiles without evidence of immunosuppression.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE), a form of lupus, is a
systemic autoimmune disease affecting more than 200,000
Americans.1,2 SLE occurs when the immune system is activated and
attacks different parts of the body, leading to widespread
inflammation that can affect many different body parts, including a
person's joints, skin, kidneys, blood cells, brain, heart, and
lungs.2,3
Each person with SLE has slightly different
symptoms that can range from mild to severe, depending on which
body parts are affected by the disease.2 Symptoms may include
arthritis, extreme fatigue, red rashes, hair loss, sensitivity to
the sun, mouth sores, and pale or purple fingers and toes when
exposed to cold or stress.2
Although SLE is most often a disease that one
can live with for decades, it is ranked among the top 20 leading
causes of death in young women.4 Medicines specifically approved by
the FDA for treatment of SLE are aspirin, hydroxychloroquine,
corticosteroids (for example, prednisone), a repository
corticotropin injection, and the immunosuppressive drug belimumab.2
Other drugs that are not FDA-approved for SLE but are often
prescribed by physicians include methotrexate, mycophenolate,
azathioprine and cyclophosphamide. These treatments may be
associated with significant side effects, including serious
infections.
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 http://www.corbuspharma.com/, and
connect with us on Twitter, LinkedIn, and
Facebook.
About the Feinstein Institutes
The Feinstein Institutes for Medical Research is
the research arm of Northwell Health, the largest health care
provider and private employer in New York State. Home to 50
research labs, 3,000 clinical research studies and 5,000
researchers and staff, the Feinstein Institutes raises the standard
of medical innovation through its five institutes of behavioral
science, bioelectronic medicine, cancer, health innovations and
outcomes, and molecular medicine. We make breakthroughs in
genetics, oncology, brain research, mental health, autoimmunity,
and are the global scientific leader in bioelectronic medicine – a
new field of science that has the potential to revolutionize
medicine. For more information about how we produce knowledge to
cure disease, visit http://feinstein.northwell.edu and follow us on
LinkedIn.
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 statements 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
Feinstein Institutes for Medical Research
Contact:
Matthew Libassi, Lead Media Relations SpecialistPhone: +1 (631)
793-5325Email: mlibassi@northwell.edu
1. Izmirly, et al .“Prevalence of Systemic Lupus Erythematosus
in the United States: Estimates from a Meta‐Analysis of the Centers
for Disease Control and Prevention National Lupus Registries.”
Arthritis & Rheumatology, https://doi.org/10.1002/art.41632
2. “Lupus.” Mayo Clinic, Mayo Clinic, 24 March 2021,
www.mayoclinic.org/diseases-conditions/lupus/symptoms-causes/syc-20365789
3. “Systemic Lupus Erythematosus (Lupus).” National Institute of
Arthritis and Musculoskeletal and Skin Diseases, U.S. Department of
Health and Human Services, 24 March 2021,
www.niams.nih.gov/health-topics/lupus/advanced#tab-symptoms
4. Yen, et al. “Brief Report: Lupus-An Unrecognized Leading
Cause of Death in Young Females: A Population-Based Study Using
Nationwide Death Certificates, 2000-2015.” Arthritis &
Rheumatology, doi:10.1002/art.40512
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