KAER BIOTHERAPEUTICS — Department of Health and Human Services SBIR Phase II: NHLBI

Description

Acute respiratory distress syndromeARDSafflicts aboutAmericans each yearThe pathology consists of rapid onset of respiratory symptoms including radiographic bilateral opacities and pulmonary edemaThe primary risk factors for the development of ARDS are pneumoniaaspirationmajor traumasepsisand inhalation injuryDespite the adoption of lung protective ventilationthe mortality rate remains aboutCommon to all patients with ARDS is abnormal and sustained degradation of surfactantThe addition of repeated aerosol surfactant replacement therapy is hypothesized to reduce surface tension in the airways and alveoliThis decreases the transpulmonary pressure required to open atelectatic airways and collapsed alveoli with a resultant increase in respiratory capacityimproved gas exchange and the consequent resolution of the hypoxemia together with improved COremovalPatients with ARDS related to a direct insulte gpneumoniaaspirationcould most benefit from surfactant replacement therapy administered early in the course of the clinical syndrome when inflammation is present but prior to the onset of severe lung dysfunctionWe propose to developmanufacture and test alpha versions of SUPRAERClinic thatfor the first timeenables the treatment of mildearly stage ARDS patients with clinically relevant doses of fine particle aerosols of surfactant prior to the need for these patients to be intubatedSUPRAER Clinic aerosolizes a viscous surfactant suspensionevaporates water from the aerosol and concentrates this solid phase aerosol prior to its deliverySUPRAER Clinic is designed to efficiently and rapidly deliver high doses of these fine particle aerosols to patients with compromised lung function in a clinical settingSUPRAER Clinic has the provision for positive pressure respiratory assist to improve peripheral lung deposition of surfactant aerosols in these patients with heterogeneously impaired respiratory functionThe development of SUPRAER Clinic for surfactant will open up the potential for SUPRAER Clinic to deliver other agents to the lungsespecially those that comprise highly viscosity fluids that are recalcitrant to aerosol delivery by other methods!Acute respiratory distress can be precipitated by aspirationpneumoniasmoke inhalation as well as other insults to the lungs and bodyBoth lungs rapidly collapse and become stiffThere is only supportive treatment with lung protective ventilation such that the death rate is stillCommon to these patients is abnormal surfactant and it continued destruction making it hard to breatheWe propose to developmanufacture and test SUPRAER Clinica device that will deliver fine particle aerosols of a replacement surfactant that deposits in the deep lung of these patientsThis will open the air spaces and make it easier to breatheThe ability of the patients to have multiple treatments is expected to help reverse the lung damage and increase the rate of survival