Discovery Laboratories, Inc. has initiated two phase 2 clinical trials utilizing its Surfactant Replacement Therapy (SRT) to address respiratory disorders that are prevalent in premature infants in the Neonatal Intensive Care Unit (NICU).

The Company has designed a phase 2 clinical trial to assess the safety and efficacy of SurfaxinÒ for the prevention of Bronchopulmonary Dysplasia (BPD), a serious, chronic lung disease of newborn infants; and a phase 2 pilot study to evaluate the safety, tolerability and device optimization for the delivery of aerosolized SRT administered through nasal continuous positive airway pressure (nCPAP) as a non-invasive means to potentially treat neonatal respiratory failures.

The Phase 2 BPD clinical trial is a double-blind, controlled trial that will enrol up to 210 very low birth weight premature infants born at risk for developing BPD. The study objective is to determine the safety and tolerability of Surfaxin administration in the first weeks of life as a therapeutic approach for the prevention of BPD and to determine whether such treatment can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or BPD. This trial is expected to be completed by the fourth quarter of 2005.

BPD is a costly syndrome that is associated with the prolonged use of mechanical ventilation and oxygen supplementation, usually associated with a premature infant being treated for Respiratory Distress Syndrome (RDS).

Robert J. Capetola, president and CEO of Discovery commented, "These tiny premature babies are born with an insufficient amount of their own natural surfactant and are prone to devastating life-threatening diseases such as RDS and BPD. Treatments to prevent or ameliorate BPD are limited. The neonatal medical community would embrace an important medical advance such as a surfactant that can demonstrate a statistical benefit in reducing BPD compared to existing therapies. Data from our Phase 3 clinical trials for Surfaxin for RDS demonstrated a highly significant reduction in RDS related mortality and an improvement in survival of infants without BPD."

Discovery also is initiating an open label, Phase 2, multi-centre pilot study to evaluate aerosolized SRT delivered via nCPAP in premature infants. The Company's overall programme is to begin with a pilot study to evaluate the safety and tolerability of aerosolized SRT delivered via Discovery's proprietary nCPAP technology, initially within patients who suffer from RDS followed by additional studies to include other neonatal respiratory failures within the NICU. This pilot study is expected to be completed by mid 2005.