Project Grant R43HL165960

Award Date 2/10/23
Completion Date 12/31/24
Dollars Obligated $900K
Federal Grant Program
93.837
Assistance Type
Project Grant
Place of Performance
Minnesota, USA

STOP PULMONARY AIRLEAKS WITH A NOVEL INHALED DRY POWDER AEROSOL - PROJECT SUMMARY ABSTRACT OVER 30,000 AMERICANS SUFFER EACH YEAR FROM PULMONARY AIRLEAKS LEADING TO COLLAPSED LUNGS WITH PAINFUL, INVASIVE TREATMENTS, AND COSTLY HOSPITALIZATIONS. CURRENT TREATMENTS ARE NOT EFFECTIVE ENOUGH IN CONTROLLING AIRLEAKS AND MEDICAL PROVIDERS ARE SEEKING NEW THERAPIES. THERE IS STRONG EVIDENCE THAT A LOCALLY DELIVERED THERAPEUTIC VIA INHALATION WOULD HAVE A MAJOR IMPACT ON REDUCING THE BURDEN OF THIS DISEASE BY PROMOTING CLOSURE OF THE AIRLEAK DIRECTLY. HOWEVER, THERE ARE NO APPROVED THERAPIES TO ACHIEVE THE AIM OF QUICKLY RESOLVING AIRLEAKS VIA INHALATION, AND EFFECTIVE TREATMENT REMAINS A SIGNIFICANT UNMET NEED. THEREFORE, WE ARE DEVELOPING A MINIMALLY INVASIVE INHALED AEROSOL THAT AIMS TO SEAL AN AIRLEAK QUICKLY AND EFFICIENTLY IN THE LUNG TO PREVENT PAINFUL PROCEDURES AND COSTLY HOSPITALIZATIONS. THE GOAL OF THIS PHASE I PROJECT IS TO DEVELOP AND TEST THE FEASIBILITY AND EFFICACY OF OUR NOVEL INHALED DRY POWDER AEROSOL FORMULATION USING AN IN-VIVO PULMONARY AIRLEAK MODEL. SUCCESSFUL COMPLETION OF THIS PHASE I EFFORT WILL POSITION US TO DEMONSTRATE SAFETY IN AN IN-VIVO TOXICOLOGY STUDY AND PREPARE FOR A FIRST-IN-HUMAN CLINICAL STUDY. TRANSLATION OF THIS TECHNOLOGY INTO A CLINICALLY BENEFICIAL MEDICAL PRODUCT HAS THE POTENTIAL TO SIGNIFICANTLY IMPROVE THE LIVES OF PATIENTS WITH PULMONARY AIRLEAKS.

Posted 2/8/23, 12:00 AM