The company announced the issuance of US Patent No. 8,701,658 entitled ‘Ventilation Circuit Adaptor and Proximal Aerosol Delivery System’ which provides coverage for our novel disposable aerosol airway connectors which are intended to simplify the delivery of inhaled therapies including aerosolized KL4 surfactant to infants requiring ventilatory support. This patent will expire in April 2029.
Additionally, the company has received Notices of Allowance for two patents, titled ‘Lyophilization of Synthetic Liposomal Pulmonary Surfactant’.
The claims of these patents (U.S. Patent Application Numbers 14/091,608 and 14/091,712) cover composition of matter and methods of manufacturing for lyophilized KL4 surfactant. The patent term of these patents will expire in 2033. The company is initially developing its lyophilized KL4 surfactant for use in its AEROSURF® program.
Discovery Labs CEO John G. Cooper noted that the company’s goal is to build a company focused on addressing the needs of critical care patients suffering from respiratory diseases, beginning with respiratory distress syndrome in premature infants.
"These important new patents are indicative of our efforts to protect the long-term commercial potential of our platform technology. We initially are utilizing lyophilized KL4 surfactant for our AEROSURF development program. And while providing new technologies for these premature infants is our top priority, our longer term goal is to leverage our technology into developing products for other potential indications for which our proprietary KL4 surfactant could be of use," Cooper added.
Aerosurf is a novel investigational combination drug-device product being developed to deliver Discovery Labs’ synthetic, peptide-containing KL4 surfactant in aerosolized form to premature infants with respiratory distress syndrome (RDS).
Aerosurf could potentially allow for the administration of KL4 surfactant to premature infants without invasive endotracheal intubation, and may enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.
Discovery Labs has initiated a phase IIa clinical study to evaluate the safety and tolerability of aerosolized KL4 surfactant administered in escalating doses in premature infants 29 to 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to infants receiving nCPAP alone.