Corbus Pharmaceuticals completes Phase II study of JBT-101 for the treatment of cystic fibrosis

Resunab is designed to resolve inflammation thus having the potential to provide significant clinical benefit to CF patients, importantly without immunosuppression.

"We are pleased to announce the on-schedule completion of our Phase II trial evaluating JBT-101 for the treatment of cystic fibrosis. We would like to express our sincere gratitude to all the individuals, their clinicians and the clinical staff who participated in this trial," stated Yuval Cohen, CEO of the company.

The international, multi-center, double-blinded, randomized, placebo-controlled Phase II study is supported by a $5 million Development Award from Cystic Fibrosis Foundation Therapeutics. The primary objective of the study 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. Secondary objectives were to evaluate changes in pro-inflammatory and pro-resolving lipid mediators as a marker of mechanism of action of JBT-101 and to evaluate efficacy with FEV1 and Cystic Fibrosis Questionnaire Revised - Respiratory Symptom Score. Exploratory outcomes included effects of JBT-101 on biomarkers of inflammation and the sputum microbiome. Eighty-five subjects on stable standard-of-care medications were dosed with study product at 21 CF centres in the US and Europe and treated with study product daily for a period of 84 days, with a follow-up period of 28 days.

"We look forward to having our first safety data on JBT-101 in CF. Because excessive inflammation is a key driver of airway obstruction and lung damage over time in CF, resolving inflammation has the potential to provide significant clinical benefit to CF patients, importantly without immunosuppression," said Barbara White, Chief Medical Officer of the Company. "We believe that showing that JBT-101 has an acceptable safety profile in CF is a gate-keeping event for its further clinical development in CF, and we anticipate announcing top-line results before the end of the first quarter of 2017."

JBT-101 was granted Orphan Drug Designation and Fast Track status for the treatment of CF from the FDA in 2015 and was granted Orphan Drug Designation by the European Union for the treatment of CF in October 2016. The Company recently reported positive topline data results from its Phase II study in diffuse cutaneous systemic sclerosis (systemic sclerosis), showing clear signal of clinical benefit with JBT-101. Additionally, JBT-101 is being evaluated in a Phase 2, 12-month open label extension study in systemic sclerosis, a Phase II study in skin-predominant dermatomyositis, with a 12-month open label extension study in dermatomyositis and a another Phase II study in systemic lupus erythematosus ("SLE") planned to commence in the first quarter of 2017.