Corbus Pharmaceuticals Holdings, Inc. CRBP, recently announced that it has concluded Phase II trial evaluating pipeline candidate, JBT-101 (resunab), for the treatment of cystic fibrosis (CF).
Corbus’ share price has gained 17.8% in the past one month, outperforming the Zacks classified Medical-Drugs industry which has witnessed a gain of 2.5% gain in the same time frame.
The Phase II trial is a multi-center, double-blinded, randomized, placebo-controlled study. The main aim of the trial was to test safety and tolerability of JBT-101 in adults with CF who had forced expiratory volume in 1 second (FEV1) percent predicted at least 40%, without regard to their CFTR mutation, infecting pathogen, or baseline treatment. The company expects to report top-line data from the study in first-quarter 2017.
Resunab, is Corbus’ lead product candidate. It is a first-in-class, synthetic oral endocannabinoid-mimetic drug that targets chronic inflammation and fibrotic processes by triggering an endogenous pathway called "Resolution of Inflammation.”
Notably, resunab has been granted Fast Track status and Orphan Drug Designation for the treatment of CF, by the FDA and the EU, respectively. Additionally, resunab is currently being evaluated in a Phase II, 12-month open label extension study in systemic sclerosis, a Phase II study in skin-predominant dermatomyositis, while another Phase II study in systemic lupus erythematosus (SLE) is expected to start in first-quarter 2017.
Last month, the company reported positive top-line data results from its Phase II study in diffuse cutaneous systemic sclerosis ("systemic sclerosis"), displaying clear signal of clinical benefit with JBT-101. The candidate outperformed placebo in the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, reaching 33% at week 16, versus 0% for placebo.
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