Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or
the “Company”) today announced continued favorable safety and
durable improvement in efficacy outcomes at 21 months compared to
12 months in open-label extensions (OLE) of lenabasum Phase 2
studies in two rare and serious autoimmune diseases: systemic
sclerosis (SSc) and dermatomyositis (DM). These data are being
presented at the annual European Congress of Rheumatology (EULAR
2019) conference being held June 12-15, 2019 in Madrid.
“Lenabasum treatment has been safe and well
tolerated to date in studies JBT101-SSc-001 and JBT101-DM-002,
including some subjects who have received lenabasum for more than
two years. These findings support the potential for lenabasum to be
used as a chronic treatment,” said Barbara White, M.D., Chief
Medical Officer of the Company. “We are encouraged by the degree,
durability, and consistency of improvement in multiple efficacy
outcomes in subjects in both of these Phase 2 SSc and DM open label
extension studies.”
Safety & Efficacy Outcomes in
Systemic Sclerosis (SSc):
- Durable improvement was observed in
the ACR CRISS score, which remained ≥ 0.95 from month 12 through
month 21 in the OLE, and in change in mRSS, which improved > 9.8
points during the same time. An ACR CRISS score of ≥ 0.60 (60%) has
been reported to be medically important, as has an improvement of
-4 to -5 points in mRSS.
- 81% of subjects were still enrolled
in the OLE at month 21.
- Patient and physician global
assessments of health, skin symptoms, itch, and patient-reported
disability and function showed either stabilization or increasing
improvement during the OLE from month 12 through 21.
- Mean FVC % predicted declined -3.2%
from study start through latest data cut in March 2019.
- No severe AEs or study
discontinuations related to lenabasum to date in these
studies.
- 35 of 36 subjects (97%) had ≥ 1 AE
during ≥ 21 months dosing the OLE, for a total of 249 AEs in the
OLE through March 5, 2019.
- Seven serious AEs, all unrelated to
lenabasum, occurred in 5 of 36 subjects (14%): 1 each of
scleroderma renal crisis, thrombocytopenic microangiopathy, iron
deficiency anemia, multiple fractures, herpes zoster; and 2 AEs
each of ischemic digital ulcers.
- AEs leading to study
discontinuation, both unrelated to lenabasum, occurred in 2 of 36
subjects (6%): tendonitis and scleroderma renal crisis.
- AEs possibly related to lenabasum
occurred in 4 of 36 subjects (11%). Three of 36 subjects (8%) had
AEs judged to be probably or definitely related to lenabasum: 1 had
mild fatigue, 1 had a moderate skin ulcer and moderate lymph node
pain, and 1 had mild disturbance in attention, mild lethargy, and
moderate feeling abnormal.
Efficacy and safety of lenabasum in SSc is
currently being evaluated in the Company’s international,
multicenter RESOLVE-1 Phase 3 study, with data expected in the
summer of 2020. Lenabasum has been granted Orphan Drug Designation
and Fast Track designation for the treatment of SSc from the FDA
and Orphan Designation for the treatment of SSc from the EMA.
Lenabasum is not approved for the treatment of systemic
sclerosis.
Safety & Efficacy Outcomes in
Dermatomyositis (DM):
- The Cutaneous Dermatomyositis
Activity and Severity Index (CDASI) activity score continued to
improve in the OLE with a mean improvement of -21.8 points at month
16. An improvement of -4 to -5 points in CDASI activity score is
considered medically important.
- 90% of subjects were still enrolled
in the OLE at month 16.
- An increasing number of subjects
(67%) reached low disease activity at month 16, with CDASI activity
score ≤ 14.
- Continued improvement or stable
improvement from month 12 to month 16 was observed during the OLE
in patient- and physician-reported global disease activity,
physician assessment of extra-muscular disease activity,
patient-reported global assessment of skin activity, skin symptoms,
itch, hair loss, and pain.
- No serious AEs and no AEs leading
to study discontinuation occurred.
- 100% of 20 subjects had ≥ 1 AE
during ≥ 16 months dosing the OLE, for a total of 76 AEs in the OLE
through March 5, 2019.
- AEs possibly related to lenabasum
occurred in 7 (35%) subjects. One (5%) had a mild AE of fatigue
judged to be probably related to lenabasum.
- Lenabasum treatment was associated
with a reduction in skin biopsies of CD4+ T cells, CB2 expression
by T cells, interferon-β and IFN-gamma mRNA and protein expression,
IL-31 and CB2 protein expression in DM.
Efficacy and safety of lenabasum in DM is
currently being evaluated in the Company’s international,
multicenter DETERMINE Phase 3
study. Lenabasum has been granted Orphan Drug Designation for the
treatment of DM from the FDA and EMA. Lenabasum is not approved for
the treatment of dermatomyositis.
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 also 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 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 patients with
DM 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 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 Dermatomyositis
Dermatomyositis (DM), a form of myositis, is a
chronic, rare systemic autoimmune disease affecting approximately
80,000 people in the U.S., EU and Japan.1 The disease is
typically diagnosed when a person is between 50 and 60 years old,
and women are more commonly affected than men.7,8 DM is
characterized by skin rash and muscle weakness, alone or together.
DM is caused by chronic activation of the immune system, which
causes inflammation in the skin, the muscles and other organs,
damaging these body parts.
There is no cure for DM, a disease that
continues to progressively worsen over time.9,10 Typically,
people with DM are prescribed drugs that suppress the immune
system. These treatments may be associated with significant side
effects, such as serious infections.11 FDA-approved treatments
for DM include systemic corticosteroids and adrenocorticotropic
hormone analogue.12,13
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:
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
Source: Corbus Pharmaceuticals Holdings, Inc.
- 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.
- Tansley, Sarah L, et al. “Adult and Juvenile Dermatomyositis:
Are the Distinct Clinical Features Explained by Our Current
Understanding of Serological Subgroups and Pathogenic Mechanisms?”
Arthritis Research & Therapy, vol. 15, no. 2, 8 Apr. 2013, p.
211., doi:10.1186/ar4198
- Bernatsky, S, et al. “Estimating the Prevalence of Polymyositis
and Dermatomyositis from Administrative Data: Age, Sex and Regional
Differences.” Annals of the Rheumatic Diseases, vol. 68, no. 7,
July 2009, pp. 1192–1196., doi:10.1136/ard.2008.093161
- “Dermatomyositis Information Page.” National Institute of
Neurological Disorders and Stroke, U.S. Department of Health and
Human Services, 12 June 2018,
www.ninds.nih.gov/Disorders/All-Disorders/Dermatomyositis-Information-Page
- Marie, Isabelle. “Morbidity and Mortality in Adult Polymyositis
and Dermatomyositis.” Current Rheumatology Reports, vol. 14, no. 3,
2012, pp. 275–285., doi:10.1007/s11926-012-0249-3
- Dalakas, Marinos C. “Immunotherapy of Myositis: Issues,
Concerns and Future Prospects.” Nature Reviews Rheumatology, vol.
6, no. 3, Mar. 2010, pp. 129–137., doi:10.1038/nrrheum.2010.2
- FDA label Orapred ODT, available at
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- FDA label H.P. Acthar gel, available at
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