Full Press Release Details
Pharmaceuticals Announces Phase 2b Study of Lenabasum for Treatment of Cystic Fibrosis Did Not Meet Primary Endpoint
MA, October 6, 2020 - 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.
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.
topline data will be presented at the upcoming virtual North American Cystic Fibrosis Conference (NACFC), taking place
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."
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."
2b CF-002 Trial Design
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.
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
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.
is not approved for the treatment of any indication. For more information on Corbus' clinical programs, please visit here.
more information, visit www.CorbusPharma.com, and connect with us on Twitter, LinkedIn, and Facebook.
press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and
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to the Company's trial results, product development, clinical and regulatory timelines, market opportunity, competitive
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Pharmaceuticals Contacts:
Jenkins, Senior Director, Investor Relations and Corporate Communications
Phone: +1 (617) 415-7745
Email: ir@corbuspharma.com
Smith, Director, Investor Relations and Corporate Communications
Phone: +1 (617) 415-7749
Email: mediainfo@corbuspharma.com
Stern Investor Relations
Phone: +1 (212) 362-1200