Corbus Pharmaceuticals Receives FDA Orphan Drug Designation for Lenabasum for the Treatment of Dermatomyositis
July 20 2018 - 9:20AM
– Dermatomyositis is a rare chronic systemic
autoimmune disease characterized by inflammation of muscles and
skin
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or
the "Company"), a Phase 3 clinical-stage pharmaceutical company
focused on the development and commercialization of novel
therapeutics to treat rare, chronic and serious inflammatory and
fibrotic diseases, announced today that the U.S. Food and Drug
Administration (“FDA”) has granted Orphan Drug Designation (“ODD”)
to lenabasum, its novel, synthetic oral endocannabinoid-mimetic
drug, for the treatment of dermatomyositis ("DM").
The FDA Orphan Drug Designation program provides
a special status to drugs and biologics intended to treat, diagnose
or prevent diseases and disorders that affect fewer than 200,000
people in the U.S. This designation provides for a seven-year
marketing exclusivity period against competition, as well as
certain incentives, including federal grants, tax credits and a
waiver of PDUFA filing fees.
About Dermatomyositis
Dermatomyositis is a rare and serious systemic
autoimmune condition characterized by skin and muscle involvement.
Like other autoimmune diseases, it affects more women than men and
morbidity is more severe in black, Asian and Native American
populations. The disease is characterized by distinct skin lesions
that can be accompanied by erosions, photosensitivity, itch,
ulcers, calcinosis and hair loss as well as other abnormalities.
Muscle inflammation and atrophy is a characteristic of the disease
and can manifest as weakness. Dermatomyositis affects as many as
80,000 people in the US, EU and Japan. Mortality is high with
5-year survival of 70% and 10-year survival of 57%. Standard of
care includes antimalarial drugs and potent immunosuppressive
agents, which often lead to significant adverse effects.
About Lenabasum
Lenabasum is a synthetic, oral, small-molecule,
selective cannabinoid receptor type 2 (CB2) agonist that
preferentially binds to CB2 expressed on activated immune cells and
fibroblasts. CB2 activation triggers physiologic pathways that
resolve inflammation, speed bacterial clearance and halt fibrosis.
CB2 activation also induces the production of specialized
pro-resolving lipid mediators that activate an endogenous cascade
responsible for the resolution of inflammation and fibrosis, while
reducing production of multiple inflammatory mediators. Through
activation of CB2, lenabasum also is designed to have a direct
effect on fibroblasts to halt tissue scarring. Lenabasum is
believed to induce resolution rather than immunosuppression by
triggering biological pathways to turn "off" chronic inflammation
and fibrotic processes. Lenabasum has demonstrated promising
potency in preclinical models of inflammation and fibrosis.
Preclinical and human clinical studies have shown lenabasum to have
a favorable safety, tolerability and pharmacokinetic profile.
Further, the drug has demonstrated clinical benefit and positive
impact on inflammatory and immunological markers in Phase 2 studies
in diffuse cutaneous systemic sclerosis, dermatomyositis and cystic
fibrosis.
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 rare, chronic,
and serious inflammatory and fibrotic diseases. The Company's lead
product candidate, lenabasum, is a novel, synthetic oral
endocannabinoid-mimetic drug designed to resolve chronic
inflammation and fibrotic processes. Lenabasum is currently being
evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis,
and systemic lupus erythematosus.
For more information, please visit
www.CorbusPharma.com and connect with the Company on Twitter,
LinkedIn, Google+ 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 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.
Investor Contacts:
Institutional Investor InquiriesTed Jenkins,
Senior Director, Investor Relations and CommunicationsCorbus
Pharmaceuticals, Inc.Phone: +1 (617) 415-7745Email:
ir@corbuspharma.com
All Other Investor InquiriesJenene ThomasJenene
Thomas Communications, LLCPhone: +1 (833) 475-8247Email:
crbp@jtcir.com
Media ContactEliza Schleifstein Scient Public
RelationsPhone: + 1 (917) 763-8106 Email: eliza@scientpr.com
Source: Corbus Pharmaceuticals Holdings, Inc.
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