The Company and Description of Business	6 Months Ended
Jun. 30, 2015
The Company and Description of Business [Abstract]
The Company and Description of Business	Note 1 – The Company and Description of Business Discovery Laboratories, Inc. (referred to as “we,” “us,” or the “Company”) is a specialty biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases. Our proprietary technology platforms include a novel synthetic peptide-containing (KL4) surfactant, that is structurally similar to pulmonary surfactant, and proprietary drug delivery technologies being developed to enable efficient delivery of aerosolized KL4 surfactant. Surfactants are produced naturally in the lung and are essential for normal respiratory function and survival. We believe that our proprietary technologies may make it possible to develop a pipeline of aerosolized surfactant products to address a variety of respiratory diseases for which there are few or no approved therapies. Our development programs have been focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants. RDS is a serious respiratory condition caused by insufficient surfactant production in underdeveloped lungs of premature infants. RDS is the most prevalent respiratory disease in the neonatal intensive care unit (NICU) and can result in long-term respiratory problems, developmental delay and death. Our first KL4 surfactant, SURFAXIN® (lucinactant) Intratracheal Suspension for the prevention of RDS in premature infants at high risk for RDS, was approved in 2012 by the United States Food and Drug Administration (FDA) for the prevention of RDS in premature infants at high risk for RDS. In April 2015, we implemented a plan to voluntarily cease the commercialization of SURFAXIN and focus our resources on the development of aerosolized KL4 surfactant for respiratory diseases, beginning with AEROSURF^® for RDS in premature infants. Premature infants with severe RDS currently are treated with surfactants that can only be administered by endotracheal intubation supported with mechanical ventilation, invasive procedures that may each result in serious respiratory conditions and other complications. To avoid such complications, many neonatologists treat premature infants with less severe RDS using less invasive means, typically nasal continuous positive airway pressure (nCPAP). Unfortunately, a significant number of premature infants will respond poorly to nCPAP (an outcome referred to as nCPAP failure) and may require delayed surfactant therapy. Since neonatologists cannot predict which infants are likely to experience nCPAP failure, neonatologists are faced with difficult choices in treating infants with less severe RDS. This is because the medical outcomes for infants who experience nCPAP failure and receive delayed surfactant therapy may be less favorable than the outcomes for infants who receive surfactant therapy in the first hours of life. AEROSURF is an investigational combination drug/device product that combines our KL4 surfactant with our proprietary capillary aerosol generator (CAG) technology. With AEROSURF, neonatologists potentially will be able to administer aerosolized KL4 surfactant to premature infants supported with nCPAP alone, without having to resort to invasive intubation and mechanical ventilation. By enabling delivery of our aerosolized KL4 surfactant using less invasive means, we believe that AEROSURF will address a serious unmet medical need and potentially enable the treatment of a significantly greater number of premature infants with RDS who could benefit from surfactant therapy but are currently not treated. In May 2015, we announced the results of our AEROSURF phase 2a clinical trial in premature infants 29 to 34 week gestational age with RDS. This clinical trial was conducted in 48 premature infants 29 to 34 week gestational age who were receiving nCPAP for RDS and was an open label, single-dose study with the primary goal of evaluating the safety and tolerability of aerosolized KL4 surfactant administered in escalating inhaled doses in premature infants compared to infants receiving nCPAP alone. In addition to evaluating safety and tolerability, another key objective of this trial was to establish proof of concept for our proprietary technology platform with (1) physiological data indicating that aerosolized KL4 surfactant is being effectively delivered into the lung of premature infants, and (2) acceptable performance of the novel CAG technology in the NICU. All key objectives of this trial were met. We currently are conducting the next phases of our phase 2a clinical program, including: (i) we have completed enrollment of the first of two dose groups in an expansion study in 32 premature infants 29 to 34 week gestational age who are receiving nCPAP for RDS, primarily to evaluate safety and tolerability of aerosolized KL4 surfactant administered in higher (60 and 90 minutes) and repeat doses compared to nCPAP alone, and (ii) we expect to begin enrollment in August for a study in 32 premature infants 26 to 28 week gestational age receiving nCPAP for RDS, primarily to evaluate safety and tolerability of aerosolized KL4 surfactant administered in escalating (30 and 45 minutes) doses, with potential repeat doses, compared to nCPAP alone. In addition, as with the initial phase 2a study, we also are assessing performance of the CAG in the NICU and available physiological parameters for indications that aerosolized KL4 surfactant is being delivered to the lungs. We are also preparing for an AEROSURF phase 2b clinical trial, which is expected to be completed in mid-2016. The primary purpose of the phase 2b clinical trial will be to demonstrate evidence of efficacy on an acceptable endpoint, identify the dose regimen(s) to be used in the planned phase 3 clinical program and provide an estimate of the treatment effect (magnitude of benefit). We currently expect that the phase 2b trial will assess aerosolized KL4 surfactant administered in two escalating doses to 200 to 250 premature infants 26 to 32 week gestational age who are receiving nCPAP for RDS, compared to infants receiving nCPAP alone. We expect to conduct this trial in up to approximately 50 clinical sites within and outside the United States. With the knowledge that we gain from our efforts to develop AEROSURF for the treatment of RDS in premature infants with RDS, we believe that we may be able to leverage our proprietary aerosolized KL4 surfactant technology and our novel drug delivery technologies potentially to address serious critical care respiratory conditions affecting pediatric and adult patient populations. While we remain focused on RDS, we have explored and plan in the future to explore potential opportunities to address such respiratory conditions as acute lung injury (ALI), including acute radiation exposure to the lung (acute pneumonitis and delayed lung injury), chemical-induced ALI, and influenza-induced ALI, where there are no currently approved therapies other than supportive respiratory care. In addition, we may explore opportunities to apply KL4 surfactant therapies to treat conditions such as chronic rhinosinusitis, complications of certain major surgeries, mechanical ventilator-induced lung injury (often referred to as VILI), pneumonia, and diseases involving mucociliary clearance disorders, such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis. We believe that we have a potential opportunity to develop a broad pipeline of KL4 surfactant products and that investment in these indications could potentially yield products that may be effective to address significant unmet medical needs that also could represent significant market opportunities.

Note 1 – The Company and Description of Business

Discovery Laboratories, Inc. (referred to as “we,” “us,” or the “Company”) is a specialty biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases. Our proprietary technology platforms include a novel synthetic peptide-containing (KL4) surfactant, that is structurally similar to pulmonary surfactant, and proprietary drug delivery technologies being developed to enable efficient delivery of aerosolized KL4 surfactant. Surfactants are produced naturally in the lung and are essential for normal respiratory function and survival. We believe that our proprietary technologies may make it possible to develop a pipeline of aerosolized surfactant products to address a variety of respiratory diseases for which there are few or no approved therapies.

Our development programs have been focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants. RDS is a serious respiratory condition caused by insufficient surfactant production in underdeveloped lungs of premature infants. RDS is the most prevalent respiratory disease in the neonatal intensive care unit (NICU) and can result in long-term respiratory problems, developmental delay and death. Our first KL4 surfactant, SURFAXIN® (lucinactant) Intratracheal Suspension for the prevention of RDS in premature infants at high risk for RDS, was approved in 2012 by the United States Food and Drug Administration (FDA) for the prevention of RDS in premature infants at high risk for RDS. In April 2015, we implemented a plan to voluntarily cease the commercialization of SURFAXIN and focus our resources on the development of aerosolized KL4 surfactant for respiratory diseases, beginning with AEROSURF^® for RDS in premature infants.

Premature infants with severe RDS currently are treated with surfactants that can only be administered by endotracheal intubation supported with mechanical ventilation, invasive procedures that may each result in serious respiratory conditions and other complications. To avoid such complications, many neonatologists treat premature infants with less severe RDS using less invasive means, typically nasal continuous positive airway pressure (nCPAP). Unfortunately, a significant number of premature infants will respond poorly to nCPAP (an outcome referred to as nCPAP failure) and may require delayed surfactant therapy. Since neonatologists cannot predict which infants are likely to experience nCPAP failure, neonatologists are faced with difficult choices in treating infants with less severe RDS. This is because the medical outcomes for infants who experience nCPAP failure and receive delayed surfactant therapy may be less favorable than the outcomes for infants who receive surfactant therapy in the first hours of life.

AEROSURF is an investigational combination drug/device product that combines our KL4 surfactant with our proprietary capillary aerosol generator (CAG) technology. With AEROSURF, neonatologists potentially will be able to administer aerosolized KL4 surfactant to premature infants supported with nCPAP alone, without having to resort to invasive intubation and mechanical ventilation. By enabling delivery of our aerosolized KL4 surfactant using less invasive means, we believe that AEROSURF will address a serious unmet medical need and potentially enable the treatment of a significantly greater number of premature infants with RDS who could benefit from surfactant therapy but are currently not treated.

In May 2015, we announced the results of our AEROSURF phase 2a clinical trial in premature infants 29 to 34 week gestational age with RDS. This clinical trial was conducted in 48 premature infants 29 to 34 week gestational age who were receiving nCPAP for RDS and was an open label, single-dose study with the primary goal of evaluating the safety and tolerability of aerosolized KL4 surfactant administered in escalating inhaled doses in premature infants compared to infants receiving nCPAP alone. In addition to evaluating safety and tolerability, another key objective of this trial was to establish proof of concept for our proprietary technology platform with (1) physiological data indicating that aerosolized KL4 surfactant is being effectively delivered into the lung of premature infants, and (2) acceptable performance of the novel CAG technology in the NICU. All key objectives of this trial were met. We currently are conducting the next phases of our phase 2a clinical program, including: (i) we have completed enrollment of the first of two dose groups in an expansion study in 32 premature infants 29 to 34 week gestational age who are receiving nCPAP for RDS, primarily to evaluate safety and tolerability of aerosolized KL4 surfactant administered in higher (60 and 90 minutes) and repeat doses compared to nCPAP alone, and (ii) we expect to begin enrollment in August for a study in 32 premature infants 26 to 28 week gestational age receiving nCPAP for RDS, primarily to evaluate safety and tolerability of aerosolized KL4 surfactant administered in escalating (30 and 45 minutes) doses, with potential repeat doses, compared to nCPAP alone. In addition, as with the initial phase 2a study, we also are assessing performance of the CAG in the NICU and available physiological parameters for indications that aerosolized KL4 surfactant is being delivered to the lungs. We are also preparing for an AEROSURF phase 2b clinical trial, which is expected to be completed in mid-2016. The primary purpose of the phase 2b clinical trial will be to demonstrate evidence of efficacy on an acceptable endpoint, identify the dose regimen(s) to be used in the planned phase 3 clinical program and provide an estimate of the treatment effect (magnitude of benefit). We currently expect that the phase 2b trial will assess aerosolized KL4 surfactant administered in two escalating doses to 200 to 250 premature infants 26 to 32 week gestational age who are receiving nCPAP for RDS, compared to infants receiving nCPAP alone. We expect to conduct this trial in up to approximately 50 clinical sites within and outside the United States.

With the knowledge that we gain from our efforts to develop AEROSURF for the treatment of RDS in premature infants with RDS, we believe that we may be able to leverage our proprietary aerosolized KL4 surfactant technology and our novel drug delivery technologies potentially to address serious critical care respiratory conditions affecting pediatric and adult patient populations. While we remain focused on RDS, we have explored and plan in the future to explore potential opportunities to address such respiratory conditions as acute lung injury (ALI), including acute radiation exposure to the lung (acute pneumonitis and delayed lung injury), chemical-induced ALI, and influenza-induced ALI, where there are no currently approved therapies other than supportive respiratory care. In addition, we may explore opportunities to apply KL4 surfactant therapies to treat conditions such as chronic rhinosinusitis, complications of certain major surgeries, mechanical ventilator-induced lung injury (often referred to as VILI), pneumonia, and diseases involving mucociliary clearance disorders, such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis. We believe that we have a potential opportunity to develop a broad pipeline of KL4 surfactant products and that investment in these indications could potentially yield products that may be effective to address significant unmet medical needs that also could represent significant market opportunities.