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 the completion of patient enrollment in the
Phase 2b study evaluating the efficacy and safety of lenabasum for
the treatment of cystic fibrosis (CF). The Company expects to
report topline data from this study in the summer of 2020.
Lenabasum has Orphan Drug Designation and Fast Track status for
treatment of CF.
“We would like to take this opportunity to thank
the participants in the study as well as the investigators and
their staff,” said Barbara White, M.D., Chief Medical Officer of
Corbus. “Lenabasum represents a potential new anti-inflammatory
treatment option for people with CF and recurring pulmonary
exacerbations. Its potential benefit is without regard to CFTR
mutation or the current treatment the patient is receiving. We look
forward to announcing topline data from this study in the summer of
2020.”
Corbus has enrolled 426 individuals with CF in
the Phase 2b international, multicenter, randomized, double-blind,
placebo-controlled study that is being conducted in North America,
Europe, and Israel. Patients in the study are randomized 1:2:2 to
either receive lenabasum 5 mg twice per day, lenabasum 20 mg twice
per day or placebo twice per day for 28 weeks, with 4 weeks
follow-up off active treatment.
The primary efficacy endpoint of the Phase 2b CF
study is the event rate of pulmonary exacerbation. Secondary
efficacy outcomes include other measures of pulmonary
exacerbations, change in forced expiratory volume in 1 second
(FEV1), % predicted, and change in Cystic Fibrosis
Questionnaire-Revised respiratory domain score.
The Phase 2b CF study is funded in part by a
Development Award for up to $25 Million from the Cystic Fibrosis
Foundation.
Lenabasum was granted Orphan Drug Designation
for the treatment of CF by the FDA, Orphan Designation by the
European Medicines Agency (EMA) and granted Fast Track status by
the FDA. Lenabasum is not approved for the treatment of cystic
fibrosis.
About Lenabasum
Lenabasum is a rationally designed, oral, small
molecule that selectively binds as an agonist to the cannabinoid
receptor type 2 (CB2) and has been designed to resolve
inflammation, limit fibrosis and support tissue repair. CB2 is
preferentially expressed on activated immune cells and on
fibroblasts, muscle cells, and endothelial cells. In both animal
and human studies conducted to date, lenabasum has induced the
production of pro-resolving lipid mediators that activate
endogenous pathways which resolve inflammation and speed bacterial
clearance without immunosuppression. Data from animal models and
human clinical studies suggest that lenabasum can reduce expression
of genes and proteins involved in inflammation and fibrosis.
Lenabasum has demonstrated promising activity in animal models of
skin and lung inflammation and fibrosis in systemic sclerosis
(SSc). Lenabasum is also active in animal models of lung infection
and inflammation in cystic fibrosis and joint inflammation and
scarring in rheumatoid arthritis.
Lenabasum has demonstrated acceptable safety and
tolerability profiles in clinical studies to date. Lenabasum
treatment was associated with improvement in multiple
physician-assessed and patient-reported efficacy outcomes in Phase
2 studies in patients with diffuse cutaneous SSc and patients with
dermatomyositis with active skin involvement but not currently
active muscle involvement. Lenabasum treatment also was associated
with a lower rate of and longer time to pulmonary exacerbations in
a Phase 2 cystic fibrosis study. Additional clinical studies are
being conducted to confirm these results and support applications
for regulatory approval.
About Cystic Fibrosis Cystic
fibrosis (CF) is a chronic, rare, genetic disease caused by
mutations of the cystic fibrosis transmembrane conductance
regulator (CFTR) gene. CF affects approximately 70,000 people in
the U.S. and Europe.1
In people with CF, thick secretions build up in
the lungs, pancreas and other organs. In the lungs, the mucus
blocks airways, making it easy for bacteria to grow and infections
to occur. These infections can severely damage the lungs over time
and lead to respiratory failure.2 People affected by CF may
have trouble digesting their food and may develop diabetes as a
complication due to the disease's effect on the pancreas.3
A person with CF may also experience pulmonary
exacerbations (PEx), which are an acute worsening of inflammation
in the lungs with an increase in respiratory symptoms (for example,
cough, shortness of breath) accompanied by an acute decrease in
lung function.4 PEx are responsible for about half of
long-term decline in lung function experienced by people with CF.
More exacerbations are associated with greater lung function
decline.5 Nearly 1 in 3 people with CF require treatment for
PEx in any given year, and treatment success of PEx is currently
described as "suboptimal."6,7 PEx can cost up to $120K per
year in people with severe lung disease and are associated with
higher one-year risk of death.8,9
Despite the major advances in treatment of CF
over the last several decades, there has been a minimal reduction
in the proportion of individuals who have PEx treated with IV
antibiotics.6 Several classes of drugs have been considered to
treat the underlying inflammation, though ibuprofen is the only
anti-inflammatory drug currently recommended for the long-term
treatment of CF airway inflammation. Despite this recommendation,
very few eligible patients are prescribed ibuprofen because of side
effects and monitoring requirements.6,10
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 inflammatory
and fibrotic diseases by leveraging its pipeline of rationally
designed, endocannabinoid system-targeting drug candidates. The
Company's lead product candidate, lenabasum, is a novel, oral,
selective cannabinoid receptor type 2 (CB2) agonist rationally
designed to resolve chronic inflammation and fibrotic processes.
Lenabasum is currently being evaluated in systemic sclerosis,
cystic fibrosis, dermatomyositis and systemic lupus
erythematosus.
Corbus is also developing a pipeline of drug
candidates targeting the endocannabinoid system. The pipeline
includes CRB-4001, a 2nd generation, selective cannabinoid receptor
type 1 (CB1) inverse agonist designed to be peripherally
restricted. Potential indications for CRB-4001 include nonalcoholic
steatohepatitis (NASH), among others. Corbus expects data from a
CRB-4001 Phase 1 safety study in 2020.
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.
Corbus Pharmaceuticals Contacts:
Ted Jenkins, Senior Director, Investor Relations and Corporate
CommunicationsPhone: +1 (617) 415-7745Email:
ir@corbuspharma.com
Lindsey Smith, Associate Director, Investor Relations and
Corporate CommunicationsPhone: +1 (617) 415-7749Email:
mediainfo@corbuspharma.com
Jenene ThomasJenene Thomas Communications, LLCPhone: +1 (833)
475-8247Email: crbp@jtcir.com
1. Health Advances, LLC Analysis 2. “About Cystic Fibrosis.” CF
Foundation, Cystic Fibrosis
Foundation, www.cff.org/What-is-CF/About-Cystic-Fibrosis/ 3.
“Cystic Fibrosis-Related Diabetes.” CF Foundation, Cystic Fibrosis
Foundation, https://www.cff.org/Life-With-CF/Daily-Life/Cystic-Fibrosis-Related-Diabetes/
4. “Pulmonary Exacerbations Clinical Care Guidelines.” CF
Foundation, Cystic Fibrosis
Foundation, https://www.cff.org/Care/Clinical-Care-Guidelines/Respiratory-Clinical-Care-Guidelines/Pulmonary-Exacerbations-Clinical-Care-Guidelines/
5. Waters, Valerie, et al. “Effect of Pulmonary Exacerbations on
Long-Term Lung Function Decline in Cystic Fibrosis.” European
Respiratory Journal, vol. 40, no. 1, Jan. 2011, pp. 61–66.,
doi:10.1183/09031936.00159111 6. 2016 Patient Registry Annual Data
Report. Cystic Fibrosis Foundation, 2016 Patient Registry Annual
Data
Report, www.cff.org/Research/Researcher-Resources/Patient-Registry/2016-Patient-Registry-Annual-Data-Report.pdf
7. Schechter, Michael S. “Reevaluating Approaches to Cystic
Fibrosis Pulmonary Exacerbations.” Pediatric Pulmonology, 6 July
2018, doi:10.1002/ppul.24125 8. Rubin, Jaime L., et al. “Frequency
and Costs of Pulmonary Exacerbations in Patients with Cystic
Fibrosis in the United States.” Current Medical Research and
Opinion, vol. 33, no. 4, 9 Feb. 2017, pp. 667–674.,
doi:10.1080/03007995.2016.1277196 9. Aaron, Shawn D., et al. “A
Statistical Model to Predict One-Year Risk of Death in Patients
with Cystic Fibrosis.” Journal of Clinical Epidemiology, vol. 68,
no. 11, Nov.2015, pp. 1336–1345.,
doi:10.1016/j.jclinepi.2014.12.010 10. Cantin, André M., et al.
“Inflammation in Cystic Fibrosis Lung Disease: Pathogenesis and
Therapy.” Journal of Cystic Fibrosis, vol. 14, no. 4, July 2015,
pp. 419–430., doi:10.1016/j.jcf.2015.03.003
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