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 topline results from its 28-week Phase 2b
study of lenabasum in patients with cystic fibrosis (CF). The study
enrolled patients in the U.S., Canada and Europe at high risk for
recurrent pulmonary exacerbations (PEx). Subjects received
lenabasum or placebo added to their background treatments for CF.
The CF-002 Phase 2b trial did not meet the
primary endpoint of a statistically significant reduction in rate
of new PEx per subject per 28 weeks. Lenabasum treatment had a
favorable safety profile and was well-tolerated.
The topline data will be presented at the
upcoming virtual North American Cystic Fibrosis Conference (NACFC),
taking place October 7-23, 2020.
Barbara White, M.D., Chief Medical Officer and
Head of Research of Corbus, said, “We are very disappointed that
the study did not meet the primary endpoint. We look forward to
providing more details of study results starting tomorrow at NACFC.
We thank the participants, the staff at study sites, the Cystic
Fibrosis Foundation, and the European Cystic Fibrosis Society
Clinical Trials for their support and partnership throughout this
study.”
Yuval Cohen, Ph.D., Chief Executive Officer of
Corbus, said, “We are immensely grateful to the Cystic Fibrosis
Foundation for their invaluable support of this program from its
inception. It has been a privilege to work with the CF community
throughout this development program.”
Phase 2b CF-002 Trial Design
CF-002 was a multinational Phase 2b study
evaluating the efficacy and safety of lenabasum in CF. This was a
double-blind, randomized, placebo-controlled study, with dosing of
lenabasum at 5 mg twice per day, lenabasum 20 mg twice per day or
placebo twice per day for 28 weeks, with 4 weeks safety follow-up
off active treatment. The primary efficacy endpoint was the event
rate of new PEx per subject per 28 weeks, when the primary
definition of new PEx was physician diagnosis of PEx, prescription
of new antibiotics for that PEx starting more than 28 days after
completion of the last antibiotic course for any previous PEx, with
4 out of 12 Fuch’s criteria present in the subject. The Phase 2b CF
study was funded in part by a Development Award for up to $25
Million from the Cystic Fibrosis Foundation.
About Lenabasum
Lenabasum is a novel, oral, small molecule that
selectively binds as an agonist to the cannabinoid receptor type 2
(CB2) and resolves inflammation and limits fibrosis in animal and
human models of disease. CB2 is preferentially expressed on
activated immune cells and on fibroblasts, muscle cells, and
endothelial cells. Lenabasum has demonstrated acceptable safety and
tolerability profiles in clinical studies to date.
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 that resolves chronic inflammation and limits
fibrosis in animal and human models. Lenabasum is currently being
evaluated in dermatomyositis and systemic lupus erythematosus.
Corbus is also developing a pipeline of other 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 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
Christina Tartaglia Stern Investor Relations Phone: +1 (212)
362-1200 Email: christina.tartaglia@sternir.com
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