Edge Therapeutics Announces First Patient Randomized in Study of Intracisternal Administration of EG-1962 in Adults with Aneu...
March 13 2017 - 9:25AM
Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage
biotechnology company developing novel hospital-based therapies in
the management of acute, life-threatening conditions, today
announced randomization of the first patient in its multi-center,
controlled, open-label study of intracisternal administration of
EG-1962 in adults with aneurysmal subarachnoid hemorrhage (aSAH).
“We are pleased to have randomized the first patient in this
important study,” said Nerissa U. Ko, M.D., MAS, Professor of
Neurology at UCSF Medical Center and study investigator. “EG-1962
administered into an external ventricular drain (EVD) more than
doubled the chances of favorable clinical outcomes compared to oral
nimodipine in aSAH patients in the North American Phase 1/2 NEWTON
study. Intracisternal delivery of EG-1962 could provide another
option for patients who suffer an aSAH including those without an
EVD with the hope to improve clinical outcomes compared to standard
of care oral nimodipine.”
The cisternal study is expected to investigate the safety and
pharmacokinetic profile of EG-1962 administered directly into the
basal cisterns of the brain compared to standard of care oral
nimodipine in a group of 12 patients with aSAH. Clinical outcomes
will be assessed as well. Patients eligible for this study do not
always require an EVD although they remain at risk for delayed
neurological complications following their ruptured brain aneurysm.
Patients will be randomized on a 3:1 basis to receive either a
single dose of EG-1962 via intracisternal administration or up to a
total of 21 days of standard of care oral nimodipine taken 6 times
daily. Edge expects data from this study will be available in
2017.
“We believe EG-1962 has the potential to fundamentally improve
patient outcomes after aSAH, and intracisternal delivery could
allow access to EG-1962 for those aSAH patients who undergo
microsurgical clipping and do not currently receive an EVD,” said
Brian Leuthner, Edge’s President and Chief Executive Officer.
About EG-1962
EG-1962 is a novel polymeric microsphere containing nimodipine
suspended in a diluent of sodium hyaluronate. EG-1962 utilizes
Edge’s proprietary PrecisaTM development platform and is
designed to improve patient outcomes following aSAH. EG-1962,
administered through an EVD, is currently being studied in the
pivotal Phase 3 NEWTON 2 study. EG-1962 has been granted Fast Track
designation by the U.S. Food and Drug
Administration (FDA), and orphan drug designation by
the FDA and the European Commission.
About the NEWTON Study
In the completed North American Phase 1/2 NEWTON study, pooled
clinical outcome results showed that 60 percent of patients treated
with EG-1962 achieved a favorable outcome (scores of 6-8 as
measured by the Extended Glasgow Outcome Score [GOSE]) at 90 days
compared to 28 percent of patients in the active control standard
of care oral nimodipine arm who achieved a favorable outcome. In
addition, improved clinical outcome was supported by a reduction in
angiographic vasospasm, delayed cerebral ischemia, reduced use of
rescue therapies, and shorter intensive care and overall hospital
lengths of stay. Safety results showed that no patients experienced
EG-1962-related hypotension, compared to 17 percent of patients
treated with oral nimodipine.
About aSAH
An aSAH is a brain hemorrhage after which blood from a ruptured
aneurysm enters the subarachnoid space, the area between the middle
and deepest protective layers of the brain. Approximately 600,000
individuals worldwide suffer an aSAH annually. In the U.S.,
approximately 35,000 aSAH patients, with an average age of 52,
arrive alive at the hospital each year, and approximately 75
percent of these patients die or suffer permanent brain damage.
About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. is a clinical-stage biotechnology
company that discovers, develops and seeks to commercialize novel,
hospital-based therapies capable of transforming treatment
paradigms for the management of acute, life-threatening
neurological and other conditions. EG-1962, Edge’s lead product
candidate, has the potential to fundamentally improve patient
outcomes and transform the management of aneurysmal subarachnoid
hemorrhage, which is bleeding around the brain due to a ruptured
brain aneurysm. Edge is evaluating EG-1962 in two clinical studies:
a pivotal Phase 3 NEWTON 2 study of EG-1962 delivered via external
ventricular drain, and a study of direct intracisternal
administration of EG-1962. For additional information about Edge,
please visit www.edgetherapeutics.com.
Forward-Looking Statements
This press release and any statements of representatives of Edge
Therapeutics, Inc. related thereto that are not historical in
nature contain, or may contain, among other things, certain
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements may include, without limitation, statements with respect
to Edge’s plans, objectives, projections, expectations and
intentions and other statements identified by words such as
"projects," "may," "will," "could," "would," "should," "believes,"
"expects," "anticipates," "estimates," “seeks,” "intends," "plans,"
"potential" or similar expressions, including statements with
respect to Edge’s study of the intracisternal administration of
EG-1962, Edge’s future clinical plans, Edge’s ability to advance
its portfolio of therapies towards commercialization and the
potential effects of its products. These statements are based upon
the current beliefs and expectations of Edge’s management and are
subject to significant risks and uncertainties. Actual results may
differ significantly from those set forth in the forward-looking
statements. These forward-looking statements involve certain risks
and uncertainties that are subject to change based on various risk
factors (many of which are beyond Edge's control) as described
under the heading "Risk Factors" in Edge’s filings with the United
States Securities and Exchange Commission.
Investor Contact:
Gregory Gin
Edge Therapeutics, Inc.
Tel: 1-800-208 EDGE (3343)
Email: ggin@edgetherapeutics.com
Media Contact:
Laura Bagby
6 Degrees
Tel: 312-448-8098
Email: lbagby@6degreespr.com
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