Discovery Labs Announces Completion of Enrollment in AEROSURF® Phase 2a Dose Expansion Trial
Top-line Results Expected to be Released in Mid-November
Company Expects to Initiate AEROSURF Phase 2b Clinical Trial in Fourth Quarter of 2015
WARRINGTON, Pa., Oct. 21, 2015 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that it has completed enrollment in the AEROSURF® phase 2a dose expansion clinical trial to assess the administration of higher doses of AEROSURF in premature infants 29 to 34 week gestational age (GA) with respiratory distress syndrome (RDS). With the completion of enrollment in this trial, the Company expects to initiate its AEROSURF phase 2b trial in the fourth quarter of 2015 beginning with premature infants 29 to 32 weeks GA.
The AEROSURF phase 2a dose expansion trial is designed to expand upon the knowledge gained in the initial phase 2a clinical trial, which assessed the safety and tolerability of a single exposure of three escalating (15, 30 and 45 minutes) inhaled doses of aerosolized KL4 surfactant to 48 premature infants 29 to 34 weeks GA receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone. All key objectives in the initial trial were met, including establishment of proof of concept based on physiological data suggesting that aerosolized KL4 surfactant is being delivered into the lung of premature infants. The dose expansion trial is a multicenter, randomized, open-label, controlled study in 32 premature infants, which is designed to evaluate the safety and tolerability of aerosolized KL4 surfactant administered in higher (60 and 90 minutes) doses in premature infants 29 to 34 weeks. Additionally, the Company continues to evaluate the physiological effects of aerosolized KL4 surfactant. The Company anticipates releasing top-line results of the dose expansion study and holding an investor conference call in mid-November.
"We are pleased to have achieved another milestone in our AEROSURF development program with the completion of enrollment in the phase 2a expansion study and look forward to the start of our AEROSURF phase 2b program." commented Steve Simonson, M.D., Discovery Labs' Chief Development Officer.
In the fourth quarter of 2015, the Company expects to initiate an AEROSURF phase 2b clinical trial in up to 250 premature infants 26 to 32 week GA. The study is designed to evaluate two escalating doses (with potentially repeat doses) of aerosolized KL4 surfactant with a primary purpose of demonstrating evidence of efficacy. If successful, this study will inform the final design of a phase 3 clinical program. Enrollment in the phase 2b trial will begin with premature infants 29 to 32 weeks GA and will then be followed by premature infants 26 to 28 weeks GA following completion of the phase 2a program in this age group. The phase 2b clinical trial is expected to be completed in mid – 2016.
The Company is currently enrolling a 32-patient phase 2a clinical trial to assess the safety and tolerability of escalating (30 and 45 minutes) and potentially repeat inhaled doses of aerosolized KL4 surfactant administered to premature infants 26 to 28 week GA. The Company anticipates releasing top-line results of this phase 2a trial in the first quarter of 2016.
AEROSURF is a novel, investigational drug/device product that combines the Company's proprietary KL4 surfactant and its aerosolization technologies. AEROSURF is being developed to potentially reduce or eliminate the need for intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS). With AEROSURF, neonatologists may potentially administer aerosolized KL4 surfactant to premature infants supported by nasal continuous positive airway pressure (nCPAP), without subjecting them to invasive intubation and mechanical ventilation (each of which can result in serious respiratory conditions and other complications), which are currently required to administer surfactant therapy to premature infants. By enabling delivery of aerosolized KL4 surfactant using less invasive procedures, AEROSURF, if approved, has the potential to address a serious unmet medical need, provide transformative clinical and pharmacoeconomic benefits, and enable the treatment of a significantly greater number of premature infants with RDS who could benefit from surfactant therapy but are currently not treated.
About Discovery Labs
Discovery Laboratories, Inc. is a specialty biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lung and are essential for normal respiratory function and survival. If surfactant deficiency or degradation occurs, the air sacs in the lungs can collapse, resulting in severe respiratory diseases and disorders. Discovery Labs' technology platform includes a novel synthetic peptide-containing (KL4) surfactant, that is structurally similar to pulmonary surfactant, and proprietary drug delivery technologies being developed to enable efficient delivery of aerosolized KL4 surfactant. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of aerosolized surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies.
For more information, please visit the company's website at www.Discoverylabs.com.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those affecting Discovery Labs' ability successfully to complete its development programs and realize the potential benefits of its RDS product portfolio, are described in Discovery Labs' filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Any forward-looking statement in this release speaks only as of the date on which it is made. Discovery Labs assumes no obligation to update or revise any forward-looking statements.
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SOURCE Discovery Laboratories, Inc.