Experimental Systemic Sclerosis Therapy Resunab Enters Phase 2 Clinical Trials

Experimental Systemic Sclerosis Therapy Resunab Enters Phase 2 Clinical Trials

Clinical stage drug development company Corbus Pharmaceuticals Holdings, Inc. recently announced the enrollment of patients suffering from systemic sclerosis (SSc) in Phase 2 clinical studies of an experimental therapy called Resunab designed to treat SSc as well as several other chronic diseases and conditions.

Systemic sclerosis is an autoimmune disorder that induces an over-accumulation of collagen. Although the disease may involve various organs like lungs, digestive tract and kidneys, the most visible form appears on the skin. Patients with SS may suffer from various symptoms depending on the organ that is affected. For example, while skin-related SSc induces itching, scaring and reddish skin with visible blood vessels, patients with SSc-related symptoms in digestive tract may experience reflex esophagitis.

Similarly, patients with pulmonary SSc suffer from shortness of breath and pulmonary hypertension that may lead heart failure. Because SSc is often difficult to predict until the illness becomes recognizable, patients with mild SSc have an average of a 10-year survival, and death often results if pulmonary, heart or kidneys are involved. From a statistical standpoint, it is worth noting that three-quarters of the SSc patient population are women.

Unfortunately, no cure has yet to be developed to treat Systemic Sclerosis, but limited treatments for patients with SSc are currently available, and most of them are used to relieve the symptoms and not to treat the illness.

Recently, Corbus Pharmaceuticals Holdings, Inc. has begun testing a new drug named Resunab in the clinic. Clinical trials for the therapy have been approved by various public health organizations such as the FDA, DEA, and IRB, due to the drug’s potential to provide an effective approach to treat SS patients without any suppression of the immune system. In this trial, 36 patients suffering from SS will be treated for 84 days with a follow-up period of 28 days. The aim of this study is to evaluate the safety and tolerability of the drug as well as the mechanism of its action on humans. The trials will mainly be performed in the United States at various clinics specialized in treatment of SS illness.

“We are pleased to have met all of the regulatory requirements (FDA, DEA, IRB) to begin enrolling patients in this clinical study. The launch of this trial represents the second clinical study now underway with Resunab, following the launch of our Phase 2 dermatomyositis study last quarter and we are on schedule for the imminent launch of our Phase 2 trial of Resunab for the treatment of cystic fibrosis,” stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company. “Once these three parallel Phase 2 trials are all launched, each in a distinct rare inflammatory disease, we will have implemented our initial clinical plans with Resunab and significantly increased the potential value of our lead product candidate. We look forward to data from these studies which we expect at the end of 2016.”

If Phase 2 clinical trials with Resunab are successful, Corbus Pharmaceuticals Holdings, Inc. intends to implement initial clinical plans with the new drug Resunab and boost its potential value as a lead product candidate for treatment of SS disease in the future.

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