Corbus Pharmaceuticals Receives FDA Approval for Open-Label Extension to Its Phase 2 Trial of Resunab for Systemic Sclerosis

Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced today that the U.S. Food and Drug Administration (“FDA”) has granted approval for a 12-month open-label extension study of the ongoing Phase 2 clinical trial of Resunab for the treatment of diffuse cutaneous systemic sclerosis (“scleroderma”).
According to the news:

The goal of the open label extension study is to provide all subjects with the option of receiving Resunab following the completion of the 84-day treatment period in the ongoing double-blind placebo-controlled study and to collect long term safety and efficacy data on Resunab. All subjects in the 12-month extension study will receive Resunab, including those who received placebo in the current 84-day, double-blind placebo controlled trial. The same clinical endpoints used in the double-blinded placebo-controlled portion of the trial will be monitored throughout the 12-month extension study.

Yuval Cohen Ph.D., Chief Executive Officer of Corbus commented:

This is a noteworthy clinical milestone for Corbus, and we would like to express our gratitude to the subjects and the clinical study teams participating in the study. We are grateful for the opportunity to further the clinical development of Resunab.

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