Results of AEROSURF Phase 2a Clinical Program in Premature Infants 29 to 34 Weeks Gestational Age Presented at the 2015 Hot Topics in Neonatology Annual Meeting-, Overall Safety And Tolerability Profile Of AEROSurf Group Comparable To Control Group
Benzinga 10 years ago
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Discovery Laboratories, Inc. (NASDAQ: DSCO) today announced that data from the AEROSURF® Phase 2a clinical program in premature infants 29 to 34 weeks gestational age (GA) with respiratory distress syndrome (RDS) were presented at the 2015 Hot Topics in Neonatology Annual Meeting held December 6 - 9 in Washington D.C. The presentation, titled "Aerosolized Surfactant – Safety and Tolerability of Lucinactant for Inhalation in Preterm Infants", was made by Neil Finer, M.D, Professor Emeritus, Division of Neonatology, University of California, San Diego, and Chairman of the AEROSURF Steering Committee. Discovery Labs had previously released top-line results of the AEROSURF Phase 2a clinical program in premature infants 29 to 34 weeks GA in November 2015.
The AEROSURF phase 2a clinical program in premature infants 29 to 34 weeks GA consisted of two multicenter, randomized, open-label, controlled studies in a total of 80 premature infants receiving nasal continuous positive airway pressure (nCPAP) for RDS. The studies were designed to evaluate the safety and tolerability of aerosolized KL4 surfactant administered in five dose groups (15, 30, 45, 60 and 90 minutes), compared to infants receiving nCPAP alone. All key objectives of the program were achieved:
Overall, the safety and tolerability profile of the AEROSURF group in this phase 2a program was generally comparable to the control group.
Data suggest that AEROSURF may be reducing the incidence of nCPAP failure, which occurs when premature infants initially treated with nCPAP alone, require delayed surfactant therapy by means of invasive endotracheal intubation. Through 72 hours after the start of AEROSURF treatment, the AEROSURF-treated patients, predominantly receiving a single dose, had lower rates of nCPAP failure compared to control in each of the last three dose groups studied. nCPAP failure rates were 53% in the control group compared to 38%, 14%1 (excluding one patient who was inappropriately enrolled) and 38% in the 45, 60 and 90 minute AEROSURF dose groups, respectively.
The Company has focused its planning for the phase 2b clinical trial on the 45 and 60 minute dose groups. The combined data for these groups indicate that, through 72 hours after the start of AEROSURF treatment, AEROSURF-treated patients had a 27%1 nCPAP failure rate compared to 53% in the control group. This represents a 26% absolute reduction or a 49% relative reduction in nCPAP failure compared to control.
"Premature infants with RDS are born with immature lungs and may require surfactant therapy to sustain them in the first hours of life and for up to 48 to 72 hours. Currently in the United States surfactant therapy is administered via endotracheal intubation. Given the invasive requirements of surfactant administration, the current trend in neonatology is to use less- or non-invasive methods to treat RDS" commented Dr. Finer. "The AEROSURF phase 2a data thus far are encouraging because we are seeing signals suggesting that AEROSURF may be reducing nCPAP failures and intubations. If this result is confirmed by future clinical data, AEROSURF could represent a significant medical advancement in neonatology."
The Hot Topics in Neonatology Annual Meeting is an internationally recognized medical meeting dedicated to advancing the practice of neonatology and is attended by more than 1,000 neonatologists and perinatologists each year.
1 The Company previously reported top-line data that stated nCPAP failure rates in AEROSURF-treated patients were 29% for the 60 minute dose group and 33% for the 45 and 60 minute dose groups combined. These rates have been updated based on finalization of the review of data.