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 that the last subject completed their final
visit in the Company’s Phase 2b JBT101-CF-002 trial of lenabasum
for the treatment of cystic fibrosis. Topline results from the
study are on track to readout in the third quarter of 2020,
following the topline data from the RESOLVE-1 Phase 3 systemic
sclerosis study.
“Thank you to the clinical investigators and
their staff, the people with CF in the study, and our team for
their commitment and determination to complete the study on time
even in the midst of a global pandemic,” said Yuval Cohen, Ph.D,
Chief Executive Officer. “We thank the Cystic Fibrosis Foundation
for providing disease expertise and financial support to facilitate
the design and execution of this study.”
The Phase 2b trial is a multinational,
426-subject study evaluating the efficacy and safety of lenabasum
in cystic fibrosis. This is 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 is the event rate
of pulmonary exacerbation (PEx). Secondary efficacy outcomes
include other measures of PEx, 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 has been granted Orphan Drug
designation and Fast Track designation for the treatment of cystic
fibrosis by the U.S. Food and Drug Administration (FDA) and Orphan
Designation for the treatment of cystic fibrosis from the European
Medicines Agency (EMA).
About Lenabasum
Lenabasum is a rationally designed, oral, small
molecule that selectively binds as an agonist to the cannabinoid
receptor type 2 (CB2), resolves inflammation, and limits fibrosis.
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.
Lenabasum is not approved for the treatment of
systemic sclerosis, dermatomyositis, cystic fibrosis or systemic
lupus erythematosus.
About Cystic Fibrosis
Cystic fibrosis (CF) is a chronic, rare, genetic
disease affecting approximately 70,000 people worldwide. 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, limiting the ability to
breathe over time.1
A person with CF may experience pulmonary
exacerbations (PEx), which are an acute worsening of inflammation
in the lungs with an increase in respiratory symptoms (e.g., cough,
shortness of breath) accompanied by an acute decrease in lung
function.2 Despite advances in treatment of CF, patients still
face high risk and treatment burden from PEx.
1 in 3 people with CF require treatment for PEx
in any given year. On average, patients spend nearly 18 days
hospitalized for PEx per year. 3 More exacerbations are associated
with greater lung function decline.4
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 its
Phase 1 safety study in 2020.
Lenabasum is not approved for the treatment of
systemic sclerosis, dermatomyositis, cystic fibrosis or systemic
lupus erythematosus. CRB-4001 is not approved for the treatment of
NASH/NAFLD. For more information on Corbus’ clinical programs,
please visit here.
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,
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
- “About Cystic Fibrosis.” CF
Foundation, Cystic Fibrosis
Foundation, www.cff.org/What-is-CF/About-Cystic-Fibrosis/
- “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/
- 2018 Patient Registry Annual Data
Report. Cystic Fibrosis Foundation, 2018 Patient Registry Annual
Data
Report, https://www.cff.org/Research/Researcher-Resources/Patient-Registry/2018-Patient-Registry-Annual-Data-Report.pdf
- 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
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