Corbus Pharmaceuticals, a publicly held drug development company focused on rare, chronic, serious inflammatory and fibrotic diseases, has announced a development award of up to $25 million from the Cystic Fibrosis Foundation.
The funding will enable the company to execute a Phase 2b study of its pro-resolving drug lenabasum in approximately four hundred and fifteen people with CF who are at least 12 years old and at increased risk for pulmonary exacerbations. Pulmonary exacerbations are severe inflammatory events in CF associated with acute worsening of respiratory symptoms and sometimes irreversible loss of lung function.
Lenabasum, which was granted Orphan Drug Designation and Fast Track status for the treatment of CF by the FDA in 2015 and Orphan Drug Status from the European Medicines Agency in 2016, is a unique investigational drug specifically designed to trigger the resolution of inflammation without immunosuppression. In March 2017, data from an eighty-five-subject double-blind randomized placebo-controlled Phase 2 study conducted by Corbus with support from an earlier $5 million award from the CF Foundation showed lenabasum treatment was associated with a reduction in the proportion of CF subjects with pulmonary exacerbations, longer time to first pulmonary exacerbation during the trial, and reduced inflammatory cells and mediators in sputum.
"We believe this award highlights the potential for lenabasum to serve as an important therapy for people living with CF by targeting a critical unmet need in all CF patients," said Corbus CEO Yuval Cohen. "We are grateful to the CF Foundation for expanding its support for our CF clinical program, including our Phase 2b clinical development program in which the event rate of pulmonary exacerbations will be the primary efficacy endpoint."