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NIH grant 1R41HL184794-01A1: Development of a nebulized peptide biologic to combat severe neutrophilic asthma
Institute: {'code': 'HL', 'abbreviation': 'NHLBI', 'name': 'National Heart Lung and Blood Institute', 'admin_org_id': '12500068', 'admin_funding_url': ''}. PI: Jessica Gilbertie. Award: $305800.
Start: 2026-09-05T00:00:00.
PROJECT SUMMARY
Asthma is a chronic inflammatory airway disease that causes cough, shortness of breath, and chest tightness.
Approximately 30% of asthmatics will not respond to standard glucocorticoid and/or bronchodilator treatment.
These individuals have airway inflammation that is characterized as non-eosinophilic, neutrophilic
inflammation. Neutrophils contribute to airway inflammation and lung damage through cytokine production,
generation of reactive oxygen species (ROS), and release of neutrophil extracellular traps (NETs). Targeting
neutrophils could be a novel treatment approach in patients with this type of severe asthma. We have
developed a platelet-derived biologic called BIO-PLY™ that has an inhibitory effect on neutrophil inflammatory
functions by decreasing NET formation and ROS production while maintaining neutrophil antibacterial activity.
In addition, BIO-PLY™ has robust anti-inflammatory properties. The Sheats lab utilizes the only animal species
other than humans known to spontaneously develop non-eosinophilic, neutrophilic asthma: the horse.
Advantages of this animal model are that disease is naturally occurring and has comparable pathophysiology
to human disease. Further, asthma exacerbations in horses are inducible; and with their long life-span, horses
provide opportunity for longitudinal studies with low-regulatory burden, greater intervention flexibility, and ready
access to large quantities of airway and peripheral blood cells, and fluid, for testing. Therefore, we will utilize
the equine asthma model to demonstrate the feasibility and safety of nebulized BIO-PLY™ in healthy horses in
vivo. Then, we will investigate the efficacy of BIO-PLY™ in an induced large animal model of non-eosinophilic,
neutrophilic asthma. Excitingly, BIO-PLY™ has been nebulized to horses with non-asthmatic pulmonary
conditions with success, supporting its feasibility and promise as a potential airway therapeutic. Collectively,
these studies will garner proof-of-concept data supporting the use of BIO-PLY™ as a novel treatment strategy
in steroid-resistant, non-eosinophilic, neutrophilic asthma. Follow up studies could include an equine clinical
trial of naturally occurring asthma to support the translation to humans in a Phase II application and support
opening an Investigational New Drug file with the FDA.document fetched 2026-09-10 22:51