Resunab is a novel oral drug designed to target the resolution of chronic inflammation and debilitating fibrosis associated with disease progression in CF across all cystic fibrosis transmembrane conductance regulator (CFTR) gene mutations.
During a pre-clinical CF animal model, the drug is said to have mitigated inflammation, reduced bacterial infection, while leading to weight loss and improving survival.
Corbus Pharmaceuticals chief medical officer Barbara White said: "Patient dosing has commenced as planned in our CF trial and we are on track to report top-line Resunab safety and efficacy data in the CF patient population at the end of 2016.
"Resunab’s novel mechanism of action is not dependent on an individual’s underlying CFTR gene mutation. As such, we believe Resunab has the potential for promising clinical benefits to all people with CF."
The international, multi-centre, double-blind, randomized, multi-dose, placebo-control trial will focus on evaluating Resunab’s safety and tolerability in up to 70 adults with CF regardless of their CFTR mutation.
Study subjects are expected to be treated with Resunab daily for a period of 84 days, with a follow-up period of 28 days.
The impact on clinical outcomes will be measured by Forced Expiratory Volume 1 (FEV1), Lung Clearance Index, Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Symptom scale, and lung microbiota.
Additionally, the researchers will assess the impact of Resunab on biomarkers of inflammation in the sputum and blood.
The Phase 2 trial is anticipated to be completed by the end of 2016.