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news.Corbus Pharmaceuticals has received clearance for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to begin a Phase II trial with Resunab to treat cystic fibrosis (CF), a chronic, life-threatening, genetic disease.
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The company intends to begin a Phase II clinical trial with Resunab in adults with CF within the next 90 days.
CF primarily affects the lungs and digestive system and is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene.
The company said that Resunab is a new synthetic oral drug that has the potential to treat the chronic pulmonary inflammation and fibrosis associated with disease progression in CF, regardless of an individual’s specific CFTR gene mutation.
Recently, the company has also secured a $5m development award from Cystic Fibrosis Foundation Therapeutics (CFFT) to support its Phase II clinical trial of resunab for the treatment of CF.
Corbus chief medical officer Barbara White said: "The CFFT, European Cystic Fibrosis Society, and key investigators provided expert and invaluable advice on the design of our Phase II CF study, and we are grateful to them for this assistance.
"With their help, we are pleased to have achieved this important regulatory milestone for our clinical development program.
"The existing clinical safety data, as well as the pre-clinical efficacy data, points to the potential for Resunab to provide therapeutic benefit to CF patients.
"We believe that Resunab could potentially improve the clinical outcome for individuals with CF and favorably impact their lives."
Around 70 adults with CF will be enrolled in this multi-center, international, double-blind, randomized, placebo-control Phase II trial.
Participants in the trial will each be treated daily for a period of 84 days, with a follow-up period of 28 days.
The trial, designed to evaluate Resunab’s safety and tolerability, along with its potential impact on clinical outcomes as measured by FEV1, Lung Clearance Index and CFQ-R Respiratory Domain response, is expected to be completed within 18 to 21 months.
Additionally, the trial will explore multiple exploratory endpoints to determine the impact of Resunab on biomarkers for disease activity, inflammation and lung microbiota.