SOURCE: Corbus Pharmaceuticals Holdings, Inc.

Corbus Pharmaceuticals Holdings, Inc.

June 05, 2015 08:05 ET

Corbus Pharmaceuticals Expands Clinical Development of Resunab™ With a Phase 2 Trial for the Treatment of Rare Disease Dermatomyositis

Study at University of Pennsylvania School of Medicine Funded by the National Institutes of Health

NORWOOD, MA--(Marketwired - Jun 5, 2015) - Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced today that its Phase 2 clinical study with Resunab™ for the treatment of skin-predominant dermatomyositis is open for enrollment. Dermatomyositis is a rare, inflammatory muscle disease that is accompanied by skin rashes and affects up to approximately 25,000 individuals in the United States. The pathology can involve serious pulmonary, cardiovascular, and gastrointestinal involvement, has a significant burden of illness, and impairs daily functioning and quality-of-life. There are currently no FDA-approved therapies specific for dermatomyositis, and physicians commonly treat manifestations of the disease with immunosuppressive therapies that have significant toxicities.

The Phase 2 clinical trial is funded by a grant from the National Institutes of Health ("NIH") to the University of Pennsylvania School of Medicine. Victoria P. Werth, M.D., Professor of Medicine at the University of Pennsylvania School of Medicine and Chief, Dermatology, Philadelphia V.A. Hospital, is the Principal Investigator for the clinical trial. The Phase 2 trial will test safety, tolerability, clinical efficacy, biomarkers, and mechanism of action of Resunab in skin-predominant dermatomyositis. The study plans to enroll 22 adults whose skin disease is refractory to standard-of-care. These adults will receive oral Resunab or placebo once a day for 28 days, then twice a day for the next 56 days, for a total treatment duration of 84 days, with 28 days follow-up. The study is expected to end in early 2017.

"We are grateful for this opportunity to work in close collaboration with Dr. Werth and the NIH to test the safety and efficacy of Resunab in dermatomyositis in this Phase 2 trial," commented Barbara White, M.D., Chief Medical Officer of the Company. "Through its ability to activate endogenous pathways that resolve inflammation, Resunab has the potential to provide much-needed clinical benefit to these dermatomyositis patients with refractory disease."

Dr. Werth added, "As a clinical researcher and dermatologist actively involved in treating patients with dermatomyositis and other autoimmune diseases of the skin, I look forward to investigating Resunab's safety, efficacy, and impact on the disease in this patient population with skin-predominant dermatomyositis. There is a huge unmet need for safe and effective therapies for patients with dermatomyositis."

About Dermatomyositis
Dermatomyositis is a rare autoimmune disease of unknown etiology that is characterized by inflammation and subsequent damage to muscles and skin. People of any race, age, or gender can be afflicted by dermatomyositis, but it most commonly occurs in children and in adults age 50 to 70. Women develop dermatomyositis more often than men. Muscle inflammation can cause weakness, and create difficulty walking, lifting objects, climbing stairs, or swallowing. Skin involvement typically includes a distinctive reddish-purple rash on the upper eyelids, across the cheeks and bridge of the nose in a "butterfly" distribution; and scaling and changes of affected skin on the knuckles, elbows, knees, and other regions. Patients with dermatomyositis can develop interstitial lung disease and heart inflammation, which can be life-threatening, and their risk of developing cancer is increased. Dermatomyositis has a significant impact on day-to-day functioning of the patients and quality of life. Up to approximately 25,000 people in the United States suffer from this disease. There are currently no FDA-approved therapies specific for dermatomyositis.

About Resunab
Resunab™ is a novel synthetic oral drug that is a preferential agonist to the CB2 receptor expressed on activated immune cells. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Pre-clinical and Phase 1 studies have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in pre-clinical models of inflammation and fibrosis. Resunab triggers resolution of inflammation by increasing production of "Specialized Pro-resolving Lipid Mediators of Inflammation" and anti-inflammatory mediators, while reducing production of pro-inflammatory mediators and reducing numbers of immune cells in affected tissues. Resunab has direct effects on fibroblasts to halt tissue scarring. In effect, Resunab triggers endogenous pathways to turn "off" chronic inflammation and fibrotic processes, without causing immunosuppression.

About Corbus Pharmaceuticals
Corbus Pharmaceuticals is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic and serious inflammatory and fibrotic diseases. Our lead product candidate Resunab™ is a novel oral drug that resolves chronic inflammation and fibrotic processes. Resunab is scheduled to commence Phase 2 clinical trials for the treatment of cystic fibrosis, diffuse cutaneous systemic sclerosis (scleroderma), and skin-predominant dermatomyositis in 2015. For more information, please visit www.CorbusPharma.com.

Forward-Looking Statements
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