Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP) is initiating a 1-year, open-label extension trial of the underway Phase II clinical trial of Resunab for the cure of skin-predominant dermatomyositis. This extension was filed to and assessed by the U.S. Food and Drug Administration.
The goal of this trial is to provide all registered subjects with the alternative of obtaining JBT-101 for 1-year after they close the 4-month, double-blind placebo controlled part of the trial and to collect long-term efficacy and safety on JBT-101. The efficacy and safety endpoints utilized in the double-blinded, placebo-controlled part of the study will be evaluated throughout the 1-year extension study.
The expert view
Victoria P. Werth, M.D., the Principal Investigator of Phase II clinical trial of Resunab, stated that there is a clear unmet objective for effective therapeutic alternatives for individuals facing skin-predominant dermatomyositis. Since the release of the study, subjects have been very open to participating, and they expect a further understanding of the long-term efficacy and safety of JBT-101 using this study.
Barbara White, M.D, the Chief Medical Officer of Corbus, said that they are delighted to provide the subjects who complete the blinded period of the skin-predominant dermatomyositis trial the opportunity to get JBT-101 for 1-year. The efficacy and safety data generated in this comprehensive period will be noteworthy to the clinical progression of JBT-101.
Yuval Cohen, Ph.D., the CEO, said that they are extremely thrilled to execute this open-label extension in the next indication for JBT-101. It follows FDA nod of an open-label extension trial for systemic sclerosis in last April and the promising top-line Phase II clinical report in systemic sclerosis that they recently reported. They consider there is considerable overlap between these grave autoimmune diseases, and they anticipate reporting top-line report from the Phase II dermatomyositis trial in 3Q2017. It is an important achievement for the firm.