Corbus Pharmaceuticals Receives Orphan Designation for Lenabasum for the Treatment of Dermatomyositis in the European Union
September 18 2018 - 8:05AM
– 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 European Commission has
granted Orphan Designation in the European Union (“EU”) to
lenabasum, its novel, synthetic oral endocannabinoid-mimetic drug,
for the treatment of dermatomyositis (“DM”).
The Company recently announced that lenabasum
was also granted Orphan Drug Designation (“ODD”) for the treatment
of DM by the U.S. Food and Drug Administration (“FDA”).
Orphan Designation is granted by the European
Commission to drugs that are intended for the treatment, prevention
or diagnosis of life-threatening or chronically debilitating rare
diseases where no satisfactory method of diagnosis, prevention or
treatment of the condition concerned is authorized. If such a
method exists, then the medicine must be of significant benefit to
those affected by the condition. Rare diseases are those defined as
having a prevalence of not more than five per 10,000 population in
the EU. The Orphan Designation provides potential incentives for
the sponsor to develop a medicine for a rare disease, such as
protocol assistance, reduced fees, funding for clinical trials, and
protection from competition in the EU once the medicine is placed
on the market, including ten years of market exclusivity.
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 (formerly known as anabasum) is a
synthetic, oral, small-molecule, selective cannabinoid receptor
type 2 (CB2) agonist that has been shown to preferentially bind to
CB2 expressed on activated immune cells and fibroblasts in animal
studies. 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 believed to have a direct effect on
fibroblasts to halt tissue scarring. In preclinical and clinical
studies conducted so far, lenabasum has been shown 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 data and clinical studies
to date have shown lenabasum to have a favorable safety,
tolerability and pharmacokinetic profile. Data to date suggest that
the drug may have clinical benefit as well as a beneficial impact
on inflammatory and immunological markers in Phase 2 studies in
diffuse cutaneous systemic sclerosis, dermatomyositis and cystic
fibrosis. Additional clinical studies are being conducted and/or
planned to confirm these preliminary results and support
applications for regulatory approval.
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, 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.
Source: Corbus Pharmaceuticals Holdings,
Inc.
Investor Contacts:
Institutional Investor Inquiries
Ted Jenkins, Senior Director, Investor Relations and Communications
Corbus Pharmaceuticals, Inc.
Phone: +1 (617) 415-7745
Email: ir@corbuspharma.com
All Other Investor Inquiries
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (833) 475-8247
Email: crbp@jtcir.com
Media Contact
Eliza Schleifstein
Scient Public Relations
Phone: + 1 (917) 763-8106
Email: eliza@scientpr.com
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