Discovery Labs awarded NIH Fast Track SBIR grant for developing aerosolized KL4 surfactant for RDS

Dec 16 2010

Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that the Company has been awarded Phase I of a Fast Track Small Business Innovation Research Grant (SBIR) from the National Institutes of Health (NIH) to support the development of the Company's program for aerosolizing KL4 surfactant for neonatal respiratory distress syndrome (RDS). The Company submitted a proposal, with a total budget of $2.4 million, for the development of the Company's proprietary capillary aerosol generating (CAG) device technology followed by a Phase 2a clinical trial of aerosolized KL4 surfactant in preterm infants with or at risk for RDS. The Phase I grant provides $580,000 to support development efforts. The Company anticipates the potential awarding of the Phase II grant, up to an additional $1.8 million, following the conclusion of Phase I activities.

Dr. Robert Segal, Discovery Labs' Senior Vice President and the Grant Principal Investigator commented, "We are extremely pleased that the NIH has recognized the importance of our aerosolized KL4 surfactant technology, which has the potential to significantly improve the management of preterm infants with or at risk for RDS and make it possible for many more preterm infants to be treated with surfactant therapy."

RDS is one of the most prevalent medical issues facing premature infants in the neonatal intensive care unit and is a condition in which premature infants are born with a lack of natural lung surfactant and are unable to breathe. Approximately 360,000 low birth weight premature infants are born annually in the United States and at risk for RDS. Premature babies with RDS often require endotracheal intubation and mechanical ventilation. In many cases, currently available animal-derived surfactants are administered while the child is intubated. Neonatologists often try to avoid intubation and mechanical ventilation in preterm infants due to well established medical risks associated with these procedures. As a result, many neonatologists reserve intubation for infants with severe respiratory distress, where the benefits of invasive procedures clearly outweigh the associated risks.  The Company believes that the neonatal medical community increasingly recognizes the potential benefits of a synthetic, peptide-containing surfactant, and a less-invasive method of delivering surfactant, such as aerosolized KL4 surfactant. 

KL4 surfactant is a completely synthetic, peptide-containing surfactant designed to closely mimic the essential attributes of human lung surfactant. Discovery Labs is developing aerosolized KL4 surfactant for delivery in conjunction with non-invasive nasal continuous positive airway pressure (nCPAP) and other ventilation modalities. Aerosurf^®, the Company's initial aerosolized KL4 surfactant product, holds the promise to significantly expand the use of surfactant therapy in at-risk premature infants by potentially providing neonatologists with a means of administering surfactant without the risks currently associated with surfactant administration. The Company believes that Aerosurf, if approved, will allow for a potentially significant increase in the number of infants who will benefit from surfactant therapy.

Discovery Labs' lead KL4 surfactant product, Surfaxin^® for neonatal RDS, has been previously demonstrated to be generally safe and effective in a large multi-national Phase 3 clinical program. Surfaxin is the subject of a Complete Response letter from the U.S. Food and Drug Administration (FDA) and Discovery Labs expects to submit a complete response to the FDA in the first quarter of 2011. If approved, Surfaxin would be the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine.

Surfaxin and Aerosurf are investigational drugs that have not been approved by the U.S. FDA or any other world health regulatory authorities.