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FDA Grants Orphan Drug Designation to Onspira Therapeutics' Investigational Interleukin-1 Receptor Antagonist for the Treatment of Bronchiolitis Obliterans

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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.

About Onspira

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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