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.
About AEROSURF®
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.
Forward-Looking Statements
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.