US-based drug development firm Corbus Pharmaceuticals (CRBP) has started dosing in the Phase II clinical trial of its investigational new oral drug Resunab to treat cystic fibrosis (CF).
Resunab targets the resolution of chronic inflammation and debilitating fibrosis associated with disease progression in CF across all cystic fibrosis transmembrane conductance regulator (CFTR) gene mutations.
The company noted that in a pre-clinical CF animal model, the drug ameliorated 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 trial is designed to evaluate Resunab’s safety and tolerability in up to 70 adults with CF regardless of their CFTR mutation.
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In the trial, subjects will be given Resunab daily for a period of 84 days, with a follow-up period of 28 days.
University Hospitals Rainbow Babies & Children’s Hospital pediatric pulmonary diseases specialist and principal investigator James Chmiel said: "Based on the pre-clinical and clinical safety and efficacy data reported to-date, I believe Resunab has the promise to improve outcomes for people with CF.
"Importantly, Resunab has the potential to target a significant unmet medical need in CF, without suppressing the body’s natural immune response."
The company noted that 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.
In addition, the researchers will assess the impact of Resunab on biomarkers of inflammation in the sputum and blood.
The international, multi-centre, double-blind, randomised, multi-dose, placebo-control Phase II trial is anticipated to be completed by the end of 2016.