Orphan Drug Designation Granted to Bronchiolitis Obliterans Treatment, OSP-101

This morning, August 14, 2018, the US Food and Drug Administration (FDA) granted an orphan drug designation to Onspira Therapeutics’ OSP-101, the first and only inhaled interleukin-1 receptor antagonist (IL-1Ra) for the treatment of bronchiolitis obliterans following lung transplantation.

“We are very pleased that FDA granted Orphan Drug Designation to OSP-101 for the treatment of bronchiolitis obliterans,” said Brian Lortie, president and CEO of Onspira Therapeutics, in a recent statement. “This is a significant milestone for Onspira, and we look forward to advancing the clinical program in coordination with the FDA and our advisors. Bronchiolitis obliterans is a relentless, progressive disease which causes significant mortality in affected patients, and our team is highly focused on providing an effective therapy to improve their lives.”

A form of a chronic rejection that often follows lung transplant and hematopoietic stem cell transplantation, bronchiolitis obliterans is a progressive inflammatory condition resulting in airflow obstruction and loss of function in the lung. With over 50% of patients who receive a lung transplant developing the condition within 5 years of their transplant, it is the leading cause of morbidity and mortality in the pulmonary transplant population.

Aside from bronchiolitis obliterans, OSP-101 is also being investigated for the potential treatment of other causes of bronchiolitis obliterans, such as idiopathic pulmonary fibrosis (IPF) and cystic fibrosis.

Currently, there are no approved drugs for the treatment of bronchiolitis obliterans.

“Advancing the development of novel approaches to the treatment of this terrible condition is a key priority of the Lung Transplant Foundation,” added Jeffrey Goldstein, president and founding member of the Lung Transplant Foundation. We are proud to have played a part in achieving this milestone and look forward to the further development of OSP-101.”