Within the last week, Discovery Laboratories has announced that its aerosolized KL4 surfactant has received orphan drug designation from the EU for the treatment of cystic fibrosis, and it has presented data on a new product, Afectair, which it calls “a series of proprietary ventilator circuit/patient interface connectors and related componentry” that “simplifies the delivery of any inhaled therapies to critical care patients requiring ventilatory support.”
On the subject of the KL4 orphan drug designation, Discovery Labs COO Thomas Miller commented, “Discovery Labs has successfully procured orphan designations for several respiratory disease targets for our KL4 surfactant. We now have successfully secured orphan designations for CF treatment in both the US and Europe. Our development experience to date suggests that CF may be a viable therapeutic target for our aerosolized KL4 surfactant technology.”
The company is developing aerosol delivery technology, including a capillary aerosol generator for delivery of KL4 and says that it “believes that its proprietary technology makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies.” Discovery Labs acquired the capillary aerosol technology from Philip Morris in 2005.
The newest delivery system for the company is Afectair. According to data presented at the American Association for Respiratory Care (AARC) Congress 2011, Afectair significantly increased delivery of aerosolized albuterol to patients on ventilators compared to standard circuit componentry. In addition, Discovery Labs presented posters showing that Afectair produced a particle size distribution over a wider respirable range than did the current standard of care and that it produced no increase in resistance in ventilator circuitry.
Discovery Labs Senior VP of R&D Russell Clayton commented, “Afectair provides a simplified and more intuitive solution for the delivery of inhaled therapies to patients requiring ventilatory support. Our plan to evaluate the utility of Afectair includes a series of studies with several inhaled therapies. The studies presented at the AARC Congress are the first in the series and we are very pleased with these results. We believe that Afectair has the potential to address a considerable unmet medical need and become a new standard of care for the delivery of inhaled therapies to patients requiring ventilatory support.”
The company says that it “is implementing a regulatory plan that potentially will allow for the introduction of Afectair in the United States and the European Union in 2012.”
Read the Discovery Labs press release on KL4.
Read the Discovery Labs press release on Afectair.
