Onspira Therapeutics' OSP-101 Receives Orphan Drug Designation for Bronchiolitis Obliterans

August 14, 2018
  • No currently approved drugs for Bronchiolitis Obliterans
  • OSP-101 is the first and only inhaled interleukin-1 receptor antagonist
  • Nearly 80 percent of lung transplant patients experience Bronchiolitis Obliterans by 10 years

Onspira Therapeutics announced on 8/14/18 that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational product, OSP-101, for the treatment of Bronchiolitis Obliterans (BO). BO is a progressive inflammatory condition resulting in airflow obstruction and loss of function in the lung and is considered a form of chronic rejection in transplant recipients. There are no currently approved drugs for the treatment of BO. OSP-101 is the first and only inhaled interleukin-1 receptor antagonist (IL-1Ra).

Bronchiolitis obliterans (BO) is the leading cause of morbidity and mortality in the lung transplant population. More than 50 percent of patients develop the condition within five years post-transplant and this increases to nearly 80 percent by 10 years. In addition, BO can occur following hematopoietic stem cell transplantation, and it can also be caused by exposure to certain chemicals.

“We are very pleased that FDA granted Orphan Drug Designation to OSP-101 for the treatment of Bronchiolitis Obliterans (BO). This is a significant milestone for Onspira, and we look forward to advancing the clinical program in coordination with the FDA and our advisors,” said Brian Lortie, President and CEO of Onspira Therapeutics. “BO 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.”

OSP-101 is Onspira's lead candidate. The company is also developing a treatment for idiopathic pulmonary fibrosis.

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