EXO Biologics Granted Orphan Drug Designation by FDA for EXOB-001 for Prevention of BPD in Preterm newborns.

Liège, Belgium 27 October 2022 –Exo Biologics announced that the US Food and Drug Administration (FDA) had granted Orphan Drug Designation (ODD) to EXOB-001.

Liège, Belgium 27 October 2022Exo Biologics announced that the US Food and Drug Administration (FDA) had granted Orphan Drug Designation (ODD) to EXOB-001, a novel potential EV-based therapy using Extracellular vesicles (EVs) derived from cultured human allogenic umbilical cord mesenchymal stromal cells (hMSCs) for the prevention of Bronchopulmonary Dysplasia (BPD) in preterm newborns.

“This Designation by the FDA, in addition to received Designation by the European Medicines Agency (EMA) in 2021, recognizes the critical need for treating and preventing  BPD in preterm newborns, despite the improved perinatal care,” said Hugues Wallemacq, CEO of the EXO Biologics.

About Bronchopulmonary dysplasia (BPD)

Bronchopulmonary dysplasia (BPD) is a chronic severe lung disease that primarily affects extremely premature infants (< 28 weeks gestational) who require prolonged oxygen therapy to support their breathing. Prolonged mechanical ventilation can lead to inflammation and scarring of the lungs, which disrupts their normal development and repair.

 BPD can cause various respiratory symptoms, including difficulty breathing, wheezing, coughing, and increased susceptibility to lung infections. Pathological findings in BPD patients show fewer secondary septa and alveoli with sites of emphysema, which is crucial to proper gas exchange. Inflammation is expected to be a significant contributor to the pathogenesis of BPD.

In developed countries, despite improved perinatal care, 40% of extremely preterm babies develop BPD, the most common and severe consequence of preterm birth. It remains the most common morbidity of prematurity.* BPD pursuits through life, showing reduced lung function and respiratory symptoms during childhood and young adulthood** and predisposing to a new “version” of Chronic Obstructive Pulmonary Disease. Moreover, BPD patients are at higher risk for many other complications related to prematurity*** and have a higher risk of mortality for cardiovascular reasons**** with consequently high costs for the health care system not only during the perinatal period but also after it.

About EXOB-001

EXOB -001 Investigational Medical Product (IMP) consists of a sterile suspension of allogeneic extracellular vesicles derived from cultured human umbilical cord MSCs.

About EXO Biologics

EXO Biologics is a Belgian biotech company committed to developing biopharmaceuticals using Extracellular Vesicles (EVs) to treat rare diseases with unmet medical needs. Partnering with leading academic researchers, EXO Biologics aims to set the stage for future nanomedicines.  The company’s development strategy focuses on novel drug candidates for therapeutic applications in Respiratory Diseases, Inflammatory Bowel Diseases, Neurology, and Oncology.

* Shah PS, Sankaran K, Aziz K, Allen AC, Seshia M, Ohlsson A, et al. Outcomes of preterm infants <29 weeks gestation over a 10-year period in Canada: a cause for concern? J Perinatol. (2012) (

** Moschino, Bonadies, and Baraldi 2021

*** Jobe and Bancalari 2001

****Crump et al. 2019

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