Corbus Pharma (CRBP) Receives EC Orphan Designation for Resunab as CF Treatment

October 18, 2016 7:05 AM EDT
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Corbus Pharmaceuticals Holdings, Inc. (Nasdaq: CRBP) announced that the European Commission has granted Orphan Designation in the European Union for the Company's novel synthetic oral endocannabinoid-mimetic drug, Resunab, for the treatment of cystic fibrosis ("CF").

The Company previously announced that Resunab was granted Orphan Drug Designation and Fast Track status for the treatment of CF and the treatment of systemic sclerosis in the U.S. by the Food and Drug Administration ("FDA"). Resunab is currently being evaluated in three Phase 2 trials in CF, systemic sclerosis, and dermatomyositis, respectively. A fourth National Institutes of Health-sponsored clinical study of Resunab in systemic lupus erythematosus is planned to begin in the first quarter of 2017.

"Receiving Orphan Designation for Resunab in the treatment of CF in the European Union is a noteworthy milestone in our global regulatory strategy for the clinical development of Resunab in CF," stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company.

Corbus is currently testing Resunab in CF in the U.S. and Europe in a Phase 2, double-blinded, randomized, placebo-control trial that is supported in part by a $5 million development award from the Cystic Fibrosis Foundation Therapeutics, Inc. The study enrolled 89 adults who had CF and forced expiratory volume in 1 second (FEV1) percent predicted at least 40% predicted, without respect to their CFTR mutation, infecting pathogen, or baseline treatment. This Phase 2 trial will evaluate Resunab's safety, tolerability, and potential clinical benefit, as measured by FEV1 and Cystic Fibrosis Questionnaire-Revised Respiratory Symptom scale. The trial also will test the impact of Resunab on bacterial load in the lungs and biomarkers of inflammation in the sputum and blood. As previously reported, enrollment in the trial is complete, and the trial is on track to finish in 2016, with top-line safety and efficacy results anticipated early in 2017.

"There are no approved treatments for inflammation in CF, which is the major cause of lung damage in individuals with CF," added Barbara White, M.D., Chief Medical Officer of the Company. "Resunab provided benefit in a murine model of lung inflammation in CF and in other pre-clinical models of lung inflammation and lung fibrosis. These data show Resunab's potential to improve lung inflammation and consequently potentially improve lung function and pulmonary exacerbations in people with CF. This Orphan Designation of Resunab for the treatment of CF was granted based on its potential to provide significant benefit to individuals with CF."

Orphan Designation is granted by the European Commission to drugs that are intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating rare diseases where no satisfactory method of diagnosis, prevention or treatment of the condition concerned is authorized. If such a method exists, then the medicine must be of significant benefit to those affected by the condition. Rare diseases are those defined as having a prevalence of not more than five per 10,000 population in Europe. The Orphan Designation provides potential incentives from the European Union to develop a medicine for a rare disease, such as protocol assistance, reduced fees, funding from the European Commission for clinical trials, and protection from competition once the medicine is placed on the market, including 10 years of market exclusivity.

For more information on the Phase 2 study with Resunab for the treatment of CF, please visit and reference Identifier NCT02465450.

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