Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or
the "Company"), a Phase 3 clinical-stage pharmaceutical company
focused on the development and commercialization of novel
therapeutics to treat rare, chronic and serious inflammatory and
fibrotic diseases, announced today that data from open-label
extensions (OLEs) of its systemic sclerosis (SSc) and
dermatomyositis (DM) Phase 2 studies are being presented at
the Annual European Congress of Rheumatology (EULAR 2018).
Key highlights from the data being presented
include:
SSc OLE 1-Year Results
- mRSS improved by a mean of -9.4 from baseline at the start of
the Phase 2 double-blind, placebo-controlled phase of the
study;
- ACR CRISS increased steadily with lenabasum treatment and
reached 92% (median), with 50% of subjects achieving a score >
95% at 1 year; and
- 77% of subjects achieved a degree of improvement in mRSS that
is considered medically meaningful (reduction ≥ 5 points), and 50%
achieved ≥ 10 points improvement in mRSS.
DM OLE 6-Month Results
- CDASI activity score improved by a mean of -15.4 points from
baseline at the start of the Phase 2 double-blind,
placebo-controlled phase of the study; and
- 88% of subjects achieved reduction ≥ 5 points, which is
considered medically meaningful, 82% achieved reduction ≥ 10
points, and 47% had reached a low CDASI activity score (≤ 14
points).
“We now have long-term safety and efficacy data
in two related, rare and serious autoimmune diseases, SSc and DM,”
Barbara White, M.D., Chief Medical Officer of the Company
stated. “I believe that the favorable safety profile and the
consistency and magnitude of changes in efficacy outcomes affirm a
durability of treatment effect for lenabasum and show a
cross-substantiation of data between the two studies. The degree of
improvement in mRSS and CRISS scores in the SSc study, and in CDASI
activity scores in the DM study are considerable, increased over
time, and strengthen our confidence that lenabasum could offer
benefit to patients with these diseases.”
Systemic Sclerosis Oral Presentation
Overview
The abstract entitled, “Safety and Efficacy of
Lenabasum (JBT-101) In Diffuse Cutaneous Systemic Sclerosis
Subjects Treated for One Year in An Open-Label Extension of Trial
JBT101-SSc-001,” (Abstract #3512) was presented in an oral
presentation by Robert Spiera, M.D., Director of the Vasculitis and
Scleroderma Program at the Hospital for Special Surgery, Weill
Cornell Medical College in New York City and Principal Investigator
of the Phase 2 and Phase 3 trials in SSc. To access the
presentation, click here.
Study Design Thirty-six
subjects with diffuse cutaneous SSc received open-label dosing with
lenabasum at 20 mg twice per day following 16-weeks participation
in the preceding double-blinded placebo-controlled phase of the
lenabasum Phase 2 study. There was an average 20-week wash-out from
investigational product prior to the start of the OLE. Twenty-seven
subjects completed 1-year follow-up in the OLE at the time of this
data-cut. Lenabasum treatment was in addition to standard-of-care
treatments for SSc, including stable doses of concomitant
immunosuppressive drugs in 94% of subjects.
Efficacy Outcomes The modified
Rodnan Skin Score (mRSS), a physician assessment of skin
involvement and the primary outcome for the upcoming Phase 3 study
of lenabasum in SSc, improved by a mean of -9.4 points from
baseline at the start of the Phase 2 study. The baseline mRSS at
study start was 24 points. At 1 year, 77% of subjects achieved a
degree of improvement in mRSS that is considered medically
meaningful (reduction ≥ 5 points), and 50% achieved ≥ 10 points
improvement in mRSS.
The ACR Composite Response Index in diffuse
cutaneous Systemic Sclerosis score (ACR CRISS) increased steadily
with lenabasum treatment and reached 92% (median), with 50% of
subjects achieving a score > 95% at 1 year. ACR CRISS is a
measure of improvement in systemic sclerosis which is based on an
exponentially weighted algorithm of change from baseline that
includes the mRSS as well as physician and patient assessments and
forced vital capacity (FVC). Patient-reported disability, function,
skin symptoms and global health all improved from study start and
OLE start.
The mRSS and ACR CRISS, responses exceeded those
seen in the 16-week double-blind placebo-controlled phase and the
6-month time point in the OLE.
Safety There were no severe or
serious AEs and no clinically significant laboratory abnormalities
related to the drug. Thirty-three (92%) subjects experienced AEs,
and 7 (19%) subjects experienced AEs related to lenabasum during
open-label dosing. AEs that occurred in ≥ 10% of subjects (n,
%) were upper respiratory tract infection (8, 22%), arthralgia,
skin ulcer, and urinary tract infection (5, 13.9% each), and
diarrhea (4, 11.1%).
Lenabasum has been granted Orphan Drug
Designation and Fast Track status for the treatment of SSc from the
FDA and Orphan Designation from the EMA. Lenabasum is currently
being evaluated in the international multicenter Phase 3 RESOLVE-1
study, a double-blind, randomized, placebo-controlled study
assessing the efficacy and safety for the treatment of diffuse
cutaneous SSc.
Dermatomyositis Poster Presentation
Overview
The abstracts entitled, “A Phase 2 Study of
Safety and Efficacy of Lenabasum (JBT-101), A Cannabinoid Receptor
Type 2 Agonist, In Refractory Skin-Predominant Dermatomyositis,”
(Abstract #3531) and “Safety and Efficacy of Lenabasum In
Refractory Skin-Predominant Dermatomyositis Subjects Treated in An
Open Label Extension of Trial JBT101-DM-001,” (Abstract #5629) will
be presented in poster presentations by Victoria Werth, M.D.,
Professor of Dermatology and Medicine at the University of
Pennsylvania School of Medicine and Principal Investigator in the
Phase 2 study. To access the poster, click here.
The DM Phase 2 study was funded by a grant from
the National Institute of Arthritis and Musculoskeletal and Skin
Diseases of the National Institutes of Health to the University of
Pennsylvania Perelman School of Medicine. For more information
about the Phase 2 study in dermatomyositis, please visit
ClinicalTrials.gov and reference identifier NCT02466243.
Study Design Twenty subjects
with refractory, skin-predominant DM received open-label dosing
with lenabasum at 20 mg twice per day following 16-weeks
participation in the preceding double-blinded placebo-controlled
part of the lenabasum Phase 2 study. There was a mean 31-week
wash-out off investigational product prior to the start of the OLE.
Seventeen subjects completed 6-months (28-weeks) follow-up in the
OLE at the time of data-cut. Lenabasum treatment was in addition to
standard-of-care treatments for DM, including stable doses of
concomitant immunosuppressive drugs in 91% of subjects.
Efficacy Outcomes At 6 months
(28 weeks), the CDASI activity score improved by a mean of -15.4
points from baseline at the start of the Phase 2 double-blind,
placebo-controlled phase of the study. The baseline CDASI activity
score at study start was 35 points. At 6 months, 88% of subjects
achieved reduction ≥ 5 points, which is considered medically
meaningful, 82% achieved reduction ≥ 10 points, and 47% had
achieved a low CDASI activity score (≤ 14 points). Patient-reported
global disease activity, global skin disease, function, pain, and
skin symptoms all improved from study start and OLE start, as did
physician global disease and skin activity assessments.
Safety There were no severe or
serious AEs and no clinically significant laboratory abnormalities
related to the drug. Thirteen (65%) subjects experienced AEs, and 5
(25%) subjects experienced AEs related to lenabasum during
open-label dosing. A DM flare, which is an episode of worsening of
the disease, was the only AE that occurred in ≥ 2 subjects,
occurring in 2 subjects (one of which experienced a reduction of 14
points in CDASI activity from study start and another of which
experienced an increase of 5 points from study start).
About Systemic Sclerosis
Systemic sclerosis is a rare and serious systemic autoimmune
rheumatic disease with an unclear etiology. Systemic sclerosis
affects approximately 90,000 people in the United States and
Europe, with disease onset typically in mid-life. About 80 percent
of SSc patients are women. The disease process in systemic
sclerosis includes activation of the immune system, with damage to
small blood vessels and fibrosis of the skin on internal organs,
including lungs, heart, kidneys, gastrointestinal tract and
musculoskeletal system. Chronic disease burden, morbidity and
mortality are significant. Ten-year mortality rates are high at
about 40-60%. Cardiopulmonary disease is the major cause of death
in SSc. Immunosuppressive medications such as oral corticosteroids,
mycophenolate, methotrexate and cyclophosphamide are used to treat
patients with more severe signs and symptoms of disease. Currently,
there are no FDA-approved treatments specifically indicated for the
treatment of systemic sclerosis, other than pulmonary artery
hypertension secondary to connective tissue diseases such as
systemic sclerosis. About Dermatomyositis
Dermatomyositis is a rare and serious systemic
autoimmune condition characterized by skin and muscle involvement.
Like other autoimmune diseases, it affects more women than men and
morbidity is more severe in black, Asian and Native American
populations. The disease is characterized by distinct skin lesions
that can be accompanied by erosions, photosensitivity, itch,
ulcers, calcinosis and hair loss as well as other abnormalities.
Muscle inflammation and atrophy is a characteristic of the disease
and can manifest as weakness. Dermatomyositis affects as many as
70,000 people in the US. Mortality is high with 5-year survival of
70% and 10-year survival of 57%. Standard of care includes
antimalarial drugs and potent immunosuppressive agents, which often
lead to significant adverse effects.
About Lenabasum
Lenabasum (formerly known as anabasum) is a
synthetic, oral, small-molecule, selective cannabinoid receptor
type 2 (CB2) agonist that preferentially binds to CB2 expressed on
activated immune cells and fibroblasts. CB2 activation triggers
physiologic pathways that resolve inflammation, speed bacterial
clearance and halt fibrosis. CB2 activation also induces the
production of specialized pro-resolving lipid mediators that
activate an endogenous cascade responsible for the resolution of
inflammation and fibrosis, while reducing production of multiple
inflammatory mediators. Through activation of CB2, lenabasum also
is designed to have a direct effect on fibroblasts to halt tissue
scarring. Lenabasum is believed to induce resolution rather than
immunosuppression by triggering biological pathways to turn "off"
chronic inflammation and fibrotic processes. Lenabasum has
demonstrated promising potency in preclinical models of
inflammation and fibrosis. Preclinical and human clinical studies
have shown lenabasum to have a favorable safety, tolerability and
pharmacokinetic profile. Further, the drug has demonstrated
clinical benefit and positive impact on inflammatory and
immunological markers in Phase 2 studies in diffuse cutaneous
systemic sclerosis, dermatomyositis and cystic fibrosis.
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 rare, chronic,
and serious inflammatory and fibrotic diseases. The Company's lead
product candidate, lenabasum, is a novel, synthetic oral
endocannabinoid-mimetic drug designed to resolve chronic
inflammation and fibrotic processes. Lenabasum is currently being
evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis,
and systemic lupus erythematosus.
For more information, please visit
www.CorbusPharma.com and connect with the Company on Twitter,
LinkedIn, Google+ 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.
Investor Contacts:
Institutional Investor InquiriesTed Jenkins,
Senior Director, Investor Relations and CommunicationsCorbus
Pharmaceuticals, Inc.Phone: +1 (617) 415-7745Email:
ir@corbuspharma.com
All Other Investor InquiriesJenene ThomasJenene
Thomas Communications, LLCPhone: +1 (833) 475-8247Email:
crbp@jtcir.com
Media ContactEliza Schleifstein Scient Public
RelationsPhone: + 1 (917) 763-8106 Email: eliza@scientpr.com
Source: Corbus Pharmaceuticals Holdings, Inc.
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