Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or
the “Company”) today announced that following a Type C meeting with
the U.S. Food and Drug Administration (FDA), Corbus will change the
primary efficacy endpoint of the ongoing RESOLVE-1 Phase 3 trial
for systemic sclerosis (SSc) in the U.S. to the American College of
Rheumatology Combined Response Index in diffuse cutaneous Systemic
Sclerosis (ACR CRISS) score at Week 52 from the current primary
endpoint, change in modified Rodnan Skin core (mRSS). The ACR CRISS
score was the primary efficacy endpoint of the Phase 2 study
evaluating lenabasum for the treatment of diffuse cutaneous SSc.
The Company remains on track to complete the RESOLVE-1 study in the
first half of 2020 and no changes to the size or length of the
study are required.
The ACR CRISS score provides a comprehensive
measure of response to treatment compared to mRSS, which only
measures skin thickening. The ACR CRISS score is calculated from
weighted changes from baseline in five core outcome measures
commonly used to evaluate treatment effect in trials for SSc: mRSS,
Health Assessment Questionnaire - Disability Index (HAQ-DI), forced
vital capacity (FVC) percent predicted, and patient and physician
global assessments of health related to SSc.
“Following a recent Type C meeting with the FDA,
we will be designating the ACR CRISS score as the primary efficacy
endpoint for the current RESOLVE-1 Phase 3 study in the U.S. In
that meeting, the FDA recognized the unmet medical needs of SSc
patients, challenges in developing drugs to treat SSc and
limitations of current endpoints for trials in SSc. The FDA
deferred selection of the primary efficacy endpoint to Corbus. The
FDA stated that the components of ACR CRISS reflect relevant
aspects of SSc, and they will consider the totality of the data
during review of any marketing application in SSc. We will pursue
discussions with other regulatory authorities to consider changing
primary efficacy outcome to ACR CRISS outside of the U.S.,” said
Barbara White, M.D., Chief Medical Officer of Corbus.
Dr. White continued, “We believe that using the
ACR CRISS score as the primary efficacy endpoint increases our
probability of success in the RESOLVE-1 study in the U.S. The ACR
CRISS score has proven more sensitive to treatment effect than mRSS
in recent trials, and we saw an encouraging treatment effect with
lenabasum compared to placebo in our Phase 2 study using this
endpoint. ACR CRISS has received provisional endorsement by the
American College of Rheumatology as an outcome measure for
interventional trials in diffuse cutaneous SSc and its use as the
primary efficacy endpoint in our Phase 3 study was recommended by
the study’s Steering Committee. We believe the study is well
powered for this primary endpoint and subject numbers, visits, and
assessments of the core items needed to calculate the ACR CRISS
scores will continue unchanged from what is currently in the Phase
3 protocol.”
In the U.S., trial protocol and the first and
third secondary efficacy endpoints of RESOLVE-1 (i.e., changes in
HAQ-DI and FVC percent predicted, respectively) remain unchanged.
Change in mRSS will become the second secondary efficacy endpoint.
Corbus remains blinded to the treatment assignment of subjects
until after database lock occurs in the first half of 2020.
About Lenabasum
Lenabasum is a rationally-designed, oral, small
molecule that selectively binds as an agonist to the cannabinoid
receptor type 2 (CB2). CB2 is preferentially expressed on activated
immune cells, fibroblasts, muscle cells, and endothelial cells. In
both animal and human studies conducted to-date, lenabasum has
induced the production of Specialized Pro-resolving lipid Mediators
(“SPMs”) that activate endogenous pathways which resolve
inflammation and speed bacterial clearance without
immunosuppression. Lenabasum is also believed to have a direct
effect on fibroblasts to limit production of fibrogenic growth
factors and extracellular connective tissue that lead to tissue
fibrosis (scarring). 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 an 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
skin-predominant dermatomyositis. ACR CRISS score was the primary
efficacy endpoint in the Phase 2 study of lenabasum in diffuse
cutaneous SSc and showed a greater treatment effect in subjects who
received lenabasum compared to placebo in that study. 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 and/or planned to
confirm these results and support applications for regulatory
approval.
About Systemic Sclerosis
Systemic sclerosis (SSc), a form of scleroderma,
is a chronic, rare systemic autoimmune disease affecting
approximately 200,000 people in the U.S., EU and Japan.1 SSc
is more common in adults and women than in men and children, and
typically occurs in people aged 30 to 50 years old.2 The
disease is characterized by chronic inflammation, fibrosis (for
example, scarring) and small blood vessel damage in multiple organs
in the body.3 Scleroderma is an autoimmune disease, but it is
unknown why the body's immune system is activated and stays active,
damaging the body's own tissue.4 SSc has the highest mortality rate
among the systemic autoimmune diseases.5 There is no cure for
systemic sclerosis, and there are no FDA-approved treatments for
this disease.6
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 endocannabinoid
system-targeting synthetic drug candidates. The Company's lead
product candidate, lenabasum, is a novel, synthetic, oral,
selective cannabinoid receptor type 2 (CB2) agonist 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 from more than 600 novel compounds targeting the
endocannabinoid system. The pipeline includes CRB-4001, a 2nd
generation, peripherally-restricted, selective cannabinoid receptor
type 1 (CB1) inverse agonist. Potential indications for CRB-4001
include NASH, among others. Corbus plans to start a Phase 1 study
of CRB-4001 in 2019, intended to be followed by a National
Institutes of Health (NIH)-funded proof-of-concept Phase 2
study.
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:
Institutional Investor InquiriesTed Jenkins,
Senior Director, Investor Relations and CommunicationsPhone: +1
(617) 415-7745Email: ir@corbuspharma.com
All Other Investor InquiriesJenene ThomasJenene
Thomas Communications, LLCPhone: +1 (833) 475-8247Email:
crbp@jtcir.com
Media InquiriesLindsey Smith, Associate
Director, Investor Relations and Corporate CommunicationsPhone: +1
(617) 415-7749Email: mediainfo@corbuspharma.com
- Health Advances, LLC Analysis
- “Scleroderma.” National Institute of Arthritis and
Musculoskeletal and Skin Diseases, U.S. Department of Health and
Human Services, 27 Aug.
2018, www.niams.nih.gov/health-topics/scleroderma/advanced#tab-risk.
- Solomon, J. J., et al. “Scleroderma Lung
Disease.” European Respiratory Review, vol. 22, no. 127, 2013,
pp. 6–19., doi:10.1183/09059180.00005512.
- Scleroderma.” National Institute of Arthritis and
Musculoskeletal and Skin Diseases, U.S. Department of Health and
Human Services, 27 Aug.
2018, www.niams.nih.gov/health-topics/scleroderma/advanced#tab-risk.
- Bulpitt, Ken J. “Early Undifferentiated Connective Tissue
Disease: III. Outcome and Prognostic Indicators in Early
Scleroderma (Systemic Sclerosis).” Annals of Internal Medicine,
vol. 118, no. 8, 15 Apr. 1993, pp. 602–609.,
doi:10.7326/0003-4819-118-8-199304150-00005.
- Scleroderma.” National Institute of Arthritis and
Musculoskeletal and Skin Diseases, U.S. Department of Health and
Human Services, 27 Aug. 2018,
www.niams.nih.gov/health-topics/scleroderma/advanced#tab-risk.
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