Full Press Release Details
Pharmaceuticals Reports 2017 Third Quarter Financial Results and Highlights Recent Corporate and Clinical Advancements
| Positive data from three consecutive Phase 2 studies in rare and serious chronic inflammatory and fibrotic diseases provides validation of anabasum's unique activity of resolving inflammation and halting fibrosis without immunosuppression | ||
| Company on track to commence Phase 3 study in systemic sclerosis, Phase 2b study in cystic fibrosis and Phase 2 study in systemic lupus erythematosus before year end | ||
| Recent public offering completed raising approximately $32.5 million in gross proceeds extends expected cash runway into Q4 2019 |
MA (November 8, 2017) - Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"),
a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced today
its financial results for the third quarter ended September 30, 2017.
Company also provided an update on its corporate progress, clinical status and anticipated milestones for anabasum, its
novel synthetic oral endocannabinoid-mimetic drug that is designed to resolve chronic inflammation and halt fibrosis in rare autoimmune
inflammatory diseases.
Clinical and Corporate Achievements
| Reported positive, statistically significant 6-month clinical data from the ongoing open-label extension ("OLE") study in systemic sclerosis ("SSc") which is a continuation of the positive double-blind placebo-controlled Phase 2 study reported in November 2016; | ||
| Reported positive, statistically significant Phase 2 results from the double-blind, randomized, placebo-controlled trial in dermatomyositis ("DM"), a rare autoimmune disease; | ||
| Raised $32.5 million in gross proceeds from a secondary public offering; | ||
| Appointed Mr. Paris Panayiotopoulos to Board of Directors; and | ||
| Awarded U.S. Patent covering the use of pharmaceutical compositions comprising anabasum for treatment of rare autoimmune, inflammatory diseases through 2034. |
are very proud that in less than four years we have successfully executed our clinical development and corporate strategy enabling
us to be in position to launch our first Phase 3 late-stage study. Over the past 12 months, we have reported positive Phase 2
clinical data in succession in three distinct rare diseases with significant morbidity and mortality and that, combined, affect
over 200,000 individuals in the US and EU," stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company. "This
important progress has positioned us for the solid implementation and execution of our four clinical studies in systemic sclerosis,
cystic fibrosis, dermatomyositis and lupus. We are looking ahead to an exciting 2018."
Sclerosis Clinical Program Update
November 5, 2017 at the American College of Rheumatology ("ACR") Annual Meeting, Corbus presented 6-month data
from the on-going OLE study in systemic sclerosis. Thirty-six subjects are participating in the ongoing OLE which followed
the conclusion of the 16-week double blind placebo controlled study. Subjects continued to improve in multiple clinical endpoints
including a mean improvement in the modified Rodnan Skin Score (mRSS) of -8.4 points (p < 0.0001) from baseline at the start
of the Phase 2 double blind placebo controlled portion of the study. 75% of subjects achieved a degree of improvement in mRSS
(reduction 5 points and > 25% baseline) that has been associated with improved survival and exceeds that previously reported
in other clinical trials or registries in systemic sclerosis. A third of the subjects reached a low mRSS 10 points. The ACR
Composite Response Index in diffuse cutaneous systemic sclerosis score (ACR CRISS) continued to increase steadily with anabasum
treatment and reached 71% (median) from study start. The speed and degree of improvement in multiple efficacy outcomes exceeds
that previously reported in other clinical studies or registries in systemic sclerosis. To access the open label data and other
five posters presented at ACR please click here.
is on track to commence a Phase 3 study of anabasum for the treatment of systemic sclerosis with the mRSS as the primary
endpoint before year end and expects to report topline results before the end of 2019.
sclerosis is a chronic, systemic autoimmune rheumatic rare disease with an unclear etiology that affects approximately 90,000
people in the United States and Europe, with disease onset typically in mid-life and lung fibrosis resulting in a 10-year mortality
rate of 40-60%. Currently, there are no FDA-approved treatments specifically indicated for the treatment of SSc, other than pulmonary
artery hypertension secondary to connective tissue diseases such as SSc.
has been granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis from the
FDA and Orphan Designation from the EMA.
Near-Term Milestones:
| Commence Phase 3 systemic sclerosis study by end of 2017; and | ||
| Report 12-month data from the on-going OLE study in mid-2018. |
Fibrosis ("CF") Clinical Program Update
March 2017, Corbus reported positive topline data from the double-blind, randomized, placebo-controlled Phase 2 study of
anabasum for the treatment of CF showing that anabasum, compared to placebo, reduced the rate of pulmonary exacerbations, reduced
multiple inflammatory biomarkers and had an acceptable safety and tolerability profile. The 16-week study was an international,
multi-center study supported by a $5 million Development Award from Cystic Fibrosis Foundation Therapeutics, Inc. Data
from this study was presented at the European Cystic Fibrosis Society ("ECFS") conference in June 2017 and
was also recently presented at the North American Cystic Fibrosis Conference ("NACFC"). To access the posters
presented at NACFC, please click here.
fibrosis is a chronic, life-threatening, genetic rare disease, characterized by chronic lung inflammation that leads to lung
damage and fibrosis that affects approximately 30,000 patients in the U.S and 75,000 patients worldwide. The current average life
expectancy for CF patients is 40 years. The harmful inflammation and accompanying fibrosis in CF damages multiple organs, impairs
organ function, reduces health-related quality of life, and is the most common cause of mortality. There remains a recognized
unmet need for safe and effective drugs that target chronic inflammation and fibrosis for the treatment of CF without the risk
of immunosuppression currently associated with existing anti-inflammatory drugs.
has been granted Orphan Drug Designation and Fast Track status for the treatment of CF by the FDA and Orphan Designation
Near-Term Milestones:
| Obtain guidance from the FDA on the protocol design for the Phase 2b CF study; | ||
| Submit Pediatric Investigational Plan to EMA; and | ||
| Commence Phase 2b clinical study by end of 2017. |
Clinical Program Update
October 2017, Corbus announced positive topline results from its Phase 2 study evaluating anabasum for the treatment of
skin-predominant dermatomyositis, demonstrating medically and statistically significant improvement in the Cutaneous Dermatomyositis
Disease Area and Severity Index (CDASI), the primary endpoint in the study. Improvements in multiple secondary patient-reported
outcomes, including a number that achieved statistical significance, reinforce the signal of activity of anabasum in dermatomyositis.
Phase 2 results of safety and primary and secondary efficacy assessments were presented in a late-breaking poster presentation
at the ACR Annual Meeting. Demographics and baseline characteristics of subjects were also presented in a second poster presentation.
To access the ACR posters please click here.
is a rare and serious systemic autoimmune condition characterized by skin and muscle inflammation that 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%. Current standard of care includes
antimalarial drugs and potent immunosuppressive agents, which often lead to significant adverse effects.
Near-Term Milestones:
| Engage regulatory authorities to review Phase 2 dermatomyositis data and determine next steps in clinical development plan; and | ||
| Report on six-month data from Phase 2 open-label extension study in mid-2018. |
Lupus Erythematosus Clinical Program Update
lupus erythematosus ("SLE") is a prototypical autoimmune disease in which the innate immune system is chronically
activated by immune complexes containing autoantibodies and self-antigens, which leads to widespread inflammation and tissue damage.
According to the CDC, SLE affects between 161,000 - 322,000 people in the United States and has many manifestations, including
arthritis, rash, photosensitivity, oral ulcers, pleuritis, pericarditis, kidney problems, seizures and psychosis and blood cell
abnormalities. Current drugs specifically approved by the FDA for SLE are limited to aspirin, corticosteroids, hydroxychloroquine
and belimumab. Physicians commonly treat disease manifestations with immunosuppressive or corticosteroid therapies that have significant
expects that its Phase 2 clinical study evaluating anabasum for the treatment of systemic lupus erythematosus, which is being
funded by the National Institute of Health, will commence before the end of 2017.
of Financial Results for Third Quarter 2017
the three months ended September 30, 2017, the Company reported a net loss of approximately $6,966,000, or a net loss per diluted
share of $0.14, compared to a net loss of approximately $5,347,000, or a net loss per diluted share of $0.12 for the quarter ended
the nine months ended September 30, 2017, the Company reported a net loss of approximately $21,728,000, or a net loss per diluted
share of $0.44, compared to a net loss of approximately $12,428,000, or a net loss per diluted share of $0.31, for the nine months
ended September 30, 2016.
the three months ended September 30, 2017, operating expenses increased by approximately $1.7 million to $7.8 million due to increased
spending for clinical studies, manufacturing costs to produce anabasum for clinical studies, stock compensation expense and staffing
Company ended the third quarter with approximately $36.6 million of cash and cash equivalents. On October 26, 2017, the Company
completed a public offering raising approximately $32.5 million of gross proceeds. The Company expects the current cash on hand
to fund operations into the fourth quarter of 2019, based on current planned expenditures.
is a synthetic oral endocannabinoid-mimetic drug that preferentially binds to cannabinoid receptor type 2 (CB2) expressed on activated
immune cells and fibroblasts. CB2 activation triggers physiologic pathways that resolve inflammation, speed bacterial clearance
and halt fibrosis. Nonclinical and human clinical studies to date have shown anabasum has favorable safety, tolerability and pharmacokinetic
profiles. It has also demonstrated promising potency in nonclinical models of inflammation and fibrosis. Anabasum is designed
to trigger 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. Anabasum also is
designed to have a direct effect on fibroblasts to halt tissue scarring. In effect, anabasum is believed to trigger endogenous
pathways to turn "off" chronic inflammation and fibrotic processes without causing immunosuppression.
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, anabasum, is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and fibrotic
processes. Anabasum has generated positive data in three Phase 2 studies in diffuse cutaneous systemic sclerosis, cystic fibrosis