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 that the results from its completed North American Phase
1/2 clinical study of EG-1962 are now available online through
Stroke, a leading peer-reviewed journal from the American Heart
Association, and are scheduled for print publication in the January
2017 issue of Stroke.
The publication, titled “Randomized, Open-Label, Phase 1/2a
Study of Intraventricular Sustained Release Nimodipine for
Subarachnoid Hemorrhage,” describes the previously reported results
of the North American Phase 1/2 NEWTON (Nimodipine
microparticles to Enhance
recovery While
reducing TOxicity after
subarachNoid hemorrhage) study of EG-1962, Edge’s
lead product candidate, in which all primary and secondary
endpoints were achieved.
The NEWTON study, a multicenter, randomized, controlled,
open-label Phase 1/2 study, evaluated the safety, tolerability and
pharmacokinetics of escalating doses of EG-1962 compared to the
current standard of care, oral nimodipine, in subjects with an
aneurysmal subarachnoid hemorrhage (aSAH). Clinical outcome results
of the North American NEWTON study 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 vasospasm, delayed cerebral ischemia, reduced use of
rescue therapies, and shorter intensive care unit (ICU) 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.
Daniel Hänggi, M.D., Chairman, Department of Neurosurgery,
University Medical Center Mannheim, Ruprecht-Karls-University,
Heidelberg, Germany, lead NEWTON investigator and the lead author,
said, “The North American NEWTON study results demonstrate
EG-1962’s potential ability to fundamentally improve outcomes for
patients suffering from an aSAH. In the study, intraventricular
EG-1962 doubled the chances of favorable clinical outcome versus
the standard of care, demonstrated a superior safety profile, and
reduced ICU and hospital length of stay compared to oral
nimodipine.”
“The publication in the Stroke journal shows why EG-1962 has the
potential to become an important new therapy for aSAH patients and
their loved ones,” said Brian A. Leuthner, Edge’s President and
Chief Executive Officer. “The favorable NEWTON study results
provide a strong rationale for conducting our pivotal Phase 3
NEWTON 2 study.”
Edge’s ongoing NEWTON 2 study is evaluating the safety and
efficacy of EG-1962 compared to the standard of care oral
nimodipine in approximately 374 adult patients who have suffered an
aSAH.
About EG-1962
EG-1962 is a novel polymeric nimodipine microparticle 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 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 2 Study
The pivotal, Phase 3 NEWTON 2 study will assess the safety and
efficacy of EG-1962 compared to standard of care oral nimodipine in
approximately 374 adult patients who have suffered an aSAH.
Patients in the experimental arm will receive a single 600 mg
intraventricular injection of EG-1962 plus placebo capsules or
tablets administered for up to 21 days. Patients in the active
comparator arm will receive a single dose of intraventricular
normal saline and up to 21 days of oral nimodipine capsules or
tablets. The primary outcome measure will be the proportion of
patients with a favorable outcome of six to eight as measured on
the Extended Glasgow Outcome Scale (GOSE) at 90 days after the
aSAH. Additional outcome measures are neurocognitive outcome at day
90 measured by the Montreal Cognitive Assessment (MoCA), safety
(including delayed cerebral infarction at day 30) and health
economic endpoints.
For additional information on NEWTON 2, please visit
ClinicalTrials.gov and enter identifier: NCT02790632.
About aSAH
An aneurysmal subarachnoid hemorrhage 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:
the 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 StatementsThis 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 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: ir@edgetherapeutics.com
Media Contact:
Laura Bagby
6 Degrees
Tel: 312-448-8098
Email: lbagby@6degreespr.com
EDGE THERAPEUTICS, INC. (NASDAQ:EDGE)
Historical Stock Chart
From Mar 2024 to Apr 2024
EDGE THERAPEUTICS, INC. (NASDAQ:EDGE)
Historical Stock Chart
From Apr 2023 to Apr 2024