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Corbus Pharmaceuticals Presents 1-Year Systemic Sclerosis and 6-Month Dermatomyositis Data from Open-Label Extension of Phase 2 Lenabasum Studies at EULAR 2018 Multiple key efficacy outcomes further improved in open-labe

Key Takeaway: Pharmaceuticals Presents 1-Year Systemic Sclerosis and 6-Month Dermatomyositis Data from Open-Label Extension of Phase 2 Lenabasum Studies at EULAR 2018 Multiple key efficacy outcomes further improved in open-label extensions of systemic sclerosis (SSc) and dermatomyositis (D

Full Press Release Details

Pharmaceuticals Presents 1-Year Systemic Sclerosis and 6-Month Dermatomyositis Data from Open-Label Extension of Phase 2 Lenabasum
Studies at EULAR 2018
Multiple key efficacy outcomes further improved in open-label extensions of systemic sclerosis (SSc) and dermatomyositis (DM) Phase 2 studies
Lenabasum continues to demonstrate a favorable safety profile with chronic dosing
SSc and DM are related, rare and serious systemic autoimmune diseases with limited treatment options
120,000 individuals with diffuse cutaneous SSc and DM in US, EU and Japan
MA (June 13, 2018) - 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
highlights from the data being presented include:
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.
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).
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."
Sclerosis Oral Presentation Overview
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,
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.
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.
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.
mRSS and ACR CRISS, responses exceeded those seen in the 16-week double-blind placebo-controlled phase and the 6-month time point
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%).
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
Poster Presentation Overview
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.
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.
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.
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.
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
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.
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.
(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.
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.
more information, please visit www.CorbusPharma.com and connect with the Company on Twitter, LinkedIn, Google+
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
Last updated: Jun 13, 2018