WARRINGTON, Pa., Dec. 29, 2015 /PRNewswire/ -- Discovery
Laboratories, Inc. (NASDAQ: DSCO), a biotechnology company
focused on developing aerosolized KL4 surfactant therapies for
respiratory diseases, today announced that it has initiated its
AEROSURF® phase 2b clinical trial in premature infants 26 to 32
weeks gestational age (GA) receiving non-invasive nasal continuous
positive airway pressure (nCPAP) for respiratory distress syndrome
(RDS). The trial is designed to evaluate premature infants
receiving aerosolized KL4 surfactant (including potentially repeat
doses) compared to nCPAP alone. Two dose groups will be
evaluated. The primary objective of the trial is to demonstrate
evidence of efficacy and, if successful, inform the design of a
phase 3 clinical program.
"Currently, surfactant therapy is primarily administered to
premature infants with RDS via invasive endotracheal intubation.
The trend in neonatology is to use less- or non-invasive methods to
treat RDS but these preclude the administration of surfactant
therapy in a timely manner. AEROSURF allows for non-invasive
delivery of aerosolized KL4 surfactant to premature infants
receiving nCPAP," commented Steve
Simonson, M.D., Discovery Labs' Chief Development Officer.
"The initiation of the phase 2b trial is an important next step to
build upon the results observed in our recently completed phase 2a
clinical trials in premature infants 29 to 34 weeks GA. Data from
these trials are encouraging and suggest that AEROSURF may reduce
the incidence of nCPAP failure and the need for intubation and
delayed surfactant therapy. If this result is confirmed as we
advance our development program, AEROSURF could represent a
significant medical advancement in neonatology."
The AEROSURF phase 2b trial is a multicenter, randomized,
controlled study with masked treatment assignment in premature
infants 26 to 32 weeks GA receiving nCPAP for RDS. The trial is
designed to evaluate aerosolized KL4 surfactant administered in two
dose groups (25 and 50 minutes), including the ability for infants
to receive repeat doses, compared to premature infants receiving
standard care of nCPAP alone. The following endpoints will be
evaluated: time to nCPAP failure (the need for intubation and
delayed surfactant therapy), incidence of nCPAP failure and
physiological parameters indicating the effectiveness of lung
function. The trial will enroll up to 250 premature infants at up
to 50 sites in the United States,
Canada, Europe and Latin
America. Enrollment in the phase 2b trial is starting with
premature infants 29 to 32 weeks GA, followed by premature infants
26 to 28 weeks GA after completion of the ongoing phase 2a trial in
this age group.
About AEROSURF®
Premature infants with severe RDS
currently are treated with surfactants that can only be
administered by endotracheal intubation supported with mechanical
ventilation, invasive procedures that may each result in serious
respiratory conditions and other complications. To avoid such
complications, many neonatologists treat infants with less severe
RDS by less invasive means, typically nCPAP. Unfortunately, a
significant number of premature infants on nCPAP will respond
poorly (an outcome referred to as nCPAP failure) and may require
delayed surfactant therapy. Since neonatologists currently
cannot predict which infants will experience nCPAP failure,
neonatologists are faced with difficult choices in treating infants
with less severe RDS. This is because the medical outcomes
for those infants who experience nCPAP failure and receive delayed
surfactant therapy may be less favorable than the outcomes for
infants who received surfactant therapy in the first hours of
life.
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 endotracheal
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 nCPAP, without
subjecting them to invasive endotracheal 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.
Currently in the U.S., the Company estimates that approximately
120,000 to 150,000 premature infants could benefit from surfactant
therapy. However, due to the risks associated with
endotracheal intubation and mechanical ventilation, only
approximately 50,000 to 60,000 of these infants currently are
treated with surfactants as the initial therapy for severe
RDS. The remaining infants with less severe RDS are usually
supported with nCPAP alone. However, a large percentage of
these infants are not adequately supported with nCPAP alone (an
outcome referred to as nCPAP failure) and thereafter may require
delayed surfactant therapy administered by endotracheal intubation
and mechanical ventilation
About Discovery Labs
Discovery Laboratories, Inc. is a
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 the timing
of Discovery Labs' planned clinical trials and its ability
successfully to complete its development programs, secure
regulatory approval of its product candidates in the U.S. and in
markets outside the U.S., 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.
