August 14, 2018
FDA Grants Orphan Drug Designation to Onspira Therapeutics’ Investigational Interleukin-1 Receptor Antagonist for the Treatment of Bronchiolitis Obliterans
WAYNE, Pa.--(BUSINESS WIRE)—Onspira Therapeutics, a privately-held clinical-stage biopharmaceutical company dedicated to developing therapies to treat rare, life threatening pulmonary diseases, announced 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. 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.”
Jeffrey Goldstein, President and Founding Member, Lung Transplant Foundation added, “Advancing the development of novel approaches to the treatment of this terrible condition is a key priority 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.”
The FDA’s Office of Orphan Products Development (OOPD) designates orphan status to drugs and biologics intended for the treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States. The designation provides certain benefits to the drug developer including the potential for seven years of market exclusivity upon FDA approval, prescription drug user fee waivers and tax credits for qualified clinical trials.
Onspira Therapeutics is a clinical-stage biopharmaceutical company focused on the development of life-changing medicines to bring hope to patients suffering from rare pulmonary diseases. Our model leverages internal, external and shared expertise to efficiently advance promising medicines against clear and validated targets where there are unmet medical needs. Patients are at the very center of what we do, and our urgency is driven by our passion to make a real difference. Our team is united in the belief that we can do more for patients with rare and serious pulmonary disorders, and that these patients deserve to have active, rich and fulfilling lives.
Our lead program, OSP-101, is the first and only IL-1 receptor antagonist delivered by inhalation directly to the lung. OSP-101 is being advanced for the treatment of Bronchiolitis Obliterans (BO) following lung transplant, and is also under evaluation for IPF, CF, and other causes of BO. Onspira is a NeXeption portfolio company. For more information, visit www.onspiratx.com.
About Bronchiolitis Obliterans (BO)
Bronchiolitis obliterans is a progressive inflammatory condition resulting in airflow obstruction and loss of function in the lung. It is a form of chronic rejection that often follows lung transplant and hematopoietic stem cell transplantation. In addition, BO can also be caused by exposure to certain chemicals. BO is the leading cause of morbidity and mortality in the pulmonary transplant population, with over 50 percent of patients who receive a lung transplant developing the condition within five years of their transplant. This increases to nearly 80 percent by 10 years. There are no currently approved drugs for the treatment of BO.
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Mike Beyer, Sam Brown, Inc.