“We look forward to having our first safety data on JBT-101 in CF,” Barbara White, MD, chief medical officer at Corbus, said in a press release. “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.”
The double-blind, randomized, and placebo-controlled trial (NCT02465450) is evaluating the safety, tolerability, and efficacy of Resunab in adults with CF with a forced expiratory volume in 1 second (FEV1) of at least 40 percent. Patients were enrolled regardless of their underlying genetic mutation, infecting pathogen, or baseline treatment. The study’s primary goal is the number of participants with treatment-emergent adverse events at day 113, a measure of the treatment’s safety and tolerability.
Secondary endpoints include Resunab’s effectiveness, as measured by changes in pro-inflammatory and pro-resolving lipid mediators. Efficacy will also be determined via FEV1, a measure of the volume of air a person can forcibly expel in one second, and via the Cystic Fibrosis Questionnaire Revised–Respiratory Symptom Score, assessing lung function.
In the study, a total of 85 patients were treated with varying doses Resunab or with placebo at 21 CF centers in the U.S. and Europe for 84 days, with a follow-up period of 28 days.
“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,” White said.
Resunab is a novel synthetic oral drug that mimics the body’s own cannabinoids (endocannabinoids); it selectively binds to the cannabinoid receptor type 2 (CB2). In humans, the endocannabinoid system (ECS) is widespread and maintains balance in the central and peripheral nervous system. Resunab is designed to resolve chronic inflammation and halt fibrosis.
The U.S. Food and Drug Administration (FDA) named Resunab an orphan drug and assigned it Fast Track status in 2015 as a potential CF treatment. The European Union also designated Resunab as an orphan drug in October 2016.
“We are pleased to announce the on-schedule completion of our Phase 2 trial evaluating JBT-101 for the treatment of cystic fibrosis,” said Yuval Cohen, PhD, chief executive officer of Corbus. “We would like to express our sincere gratitude to all the individuals, their clinicians and the clinical staff who participated in this trial.”
Resunab is also being assessed to treat patients with diffuse cutaneous systemic sclerosis (scleroderma), dermatomyositis, and systemic lupus erythematosus (SLE).