The study (NCT02465450) included 85 patients who were treated at CF centers in the United States, Belgium, France, Germany, Italy, Poland and the United Kingdom. It compared a range of dose regimens to placebo, with a main focus on the Resunab’s safety. Secondary outcomes of the treatment — which doctors maintained for 84 days with a 28-day follow-up period — included evaluation of changes in lung function and bacterial composition of sputum.
“In 2016, we achieved many significant corporate milestones and successfully advanced JBT-101 through important regulatory and clinical milestones,” Yuval Cohen, PhD, CEO of Corbus, said in a press release. “We are moving forward from a position of financial strength, enabling us to remain focused on our commitment to clinically advance JBT-101 as a potential therapy for individuals with serious inflammatory and fibrotic diseases.”
Resunab is a drug that mimics the actions of endocannabinoids — naturally occurring compounds that bind to cannabinoid receptors in the body. Resunab selectively binds to the cannabinoid receptor type 2 (CB2). Such factors have potent anti-inflammatory and antifibrotic properties.
Corbus is currently developing Resunab for several conditions besides CF including systemic sclerosis, skin-predominant dermatomyositis, and systemic lupus erythematosus.
The U.S. Food and Drug Administration has awarded Resunab both orphan drug designation and fast-track status as a therapy for CF, potentially speeding up clinical development and regulatory processes. The European Medicines Agency has also granted Resunab orphan drug designation.
Corbus, which is based in Norwood, Massachusetts, also recently announced that it will soon present new preclinical data showing that Resunab reduces inflammation in alveolar macrophages gathered from CF patients undergoing lung transplants. The drug lowered the levels of TNF-alpha (tumor necrosis factor alpha) and IL-6 (interleukin-6) — two key immune mediators in lung inflammation.