Corbus Pharma (CRBP) Completes Resunab Phase 2 in Systemic Sclerosis
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Corbus Pharmaceuticals Holdings, Inc. (Nasdaq: CRBP) announced that it has completed the Phase 2 study evaluating Resunab for the treatment of diffuse cutaneous systemic sclerosis ("systemic sclerosis"). Corbus expects to report topline data from this study in the fourth quarter of 2016.
"We are grateful to all the individuals and clinicians who participated in this study and look forward to announcing top-line data as it becomes available this quarter," stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company.
The multi-center, double-blind, randomized, placebo-controlled Phase 2 study was conducted at nine centers in the United States. This study evaluated Resunab's efficacy and safety in 42 individuals with systemic sclerosis over an 84-day treatment period and a 28-day follow-up period. The primary efficacy endpoint is the American College of Rheumatology Provisional Composite Response Index for diffuse cutaneous Systemic Sclerosis (CRISS) which predicts the probability (0-1 or 0-100% score) of improvement from baseline in randomized controlled trials in systemic sclerosis. The CRISS composite index is a weighted algorithm which includes change from baseline in five domains that are the modified Rodnan skin score, forced vital capacity % predicted, Health Assessment Questionnaire -- Disability Index, Patient Global Assessment and Physician Global Assessment. This Phase 2 study is also evaluating multiple secondary endpoints, including changes in the individual domains of the CRISS, other patient-reported outcomes, and biomarkers of inflammation and fibrosis in systemic sclerosis.
Resunab was granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis by the U.S. Food and Drug Administration ("FDA") in 2015. Corbus received approval for an open-label extension to its Phase 2 clinical study of Resunab for systemic sclerosis from the FDA in April of 2016. The open-label extension enables all the participants in the study to receive Resunab for an additional 12 months.
For more information on the Phase 2 study with Resunab for the treatment of systemic sclerosis, please visit ClinicalTrials.gov and reference Identifier NCT02465437.
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