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Discovery's surfactant technology remains in investigational drug development and has not yet been approved as safe and effective for the treatment of respiratory diseases.


Aerosurf™ via nCPAP for Neonatal Respiratory Failure
ALI/ARDS

Scientific data has demonstrated that the therapeutic use of surfactants in aerosol form have the ability to re-establish airway patency, improve pulmonary mechanics and act as an anti-inflammatory. However, use of currently available, animal-derived surfactants is not considered viable for aerosolization due to the inability to optimize formulations, the inefficiency of current delivery systems, the manufacturing requirements, the cost of goods, and the risk of chronic exposure to animal proteins.

Applying the proprietary attributes of our surfactant technology—a precision engineered version of human lung surfactant with the ability to be manufactured in large quantities—formulations are being developed in our California laboratory to potentially provide effective aerosol products.

In the case of acute asthma as well as most other respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis, endogenous lung surfactant is destroyed. If this surfactant is not replaced, the air-sacs in the lung collapse and the patient will require mechanical ventilation to survive. According to data from the Centers for Disease Control in Atlanta, asthma afflicts approximately 14 million people in the United States and its incidence rate is rising. In the United States alone, there are roughly one million emergency room visits each year due to acute asthma attacks, while the worldwide population of COPD sufferers is estimated at 100 million.

Discovery's proprietary aerosolized surfactant is currently in research and development for the therapeutic indications above and as a prophylactic treatment for ALI/ARDS.



Aerosurf via nCPAP for Neonatal Respiratory Failure

To further the Company’s commitment to potentially address the range of neonatal respiratory failures in the NICU, we have conducted an open label, Phase 2, multicenter pilot study to evaluate the feasibility, safety and tolerability of Aerosurf™, aerosolized SRT delivered via nCPAP, for the prevention of RDS in premature infants. The study showed that it is feasible to deliver Aerosurf via nCPAP and the treatment was generally safe and well tolerated.  This initial pilot trial was not designed to demonstrate efficacy outcomes.

We anticipate conducting Phase 2a pilot studies of Aerosurf utilizing the Chrysalis aerosolization technology.



ALI/ARDS

Discovery's strategy for ALI/ARDS is based on aerosolized surfactant to be delivered through the ventilator circuit. Data shows that the onset of clinically demonstrable ALI/ARDS is preceded by the breakdown of surfactant activity. Our concept is to provide exogenous surfactant prior to the onset of disease either to prevent development of disease or lessen disease severity, and to minimize the need for high cost ventilation.