Edge's EG-1962 Phase 3 NEWTON 2 Study Continues as Planned Following Completion of Futility Analysis
December 29 2017 - 4:05PM
Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage
biotechnology company developing novel hospital-based therapies for
the management of acute, life-threatening conditions, today
announced that an independent Data Monitoring Committee (DMC)
recommended that the Phase 3 NEWTON 2 study of EG-1962 continue as
planned based on the completion of a pre-planned futility analysis.
The DMC made this recommendation after evaluating data from the Day
90 follow-up visit of the first 150 patients randomized and
treated, as well as the available safety data in the study.
About the NEWTON 2 Study
The pivotal, Phase 3 NEWTON 2 study is comparing the efficacy
and safety of EG-1962 (nimodipine microparticles) compared to
standard of care oral nimodipine in up to approximately 374 adult
patients with aneurysmal subarachnoid hemorrhage (aSAH). Patients
in the experimental arm 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 receive a
single dose of intraventricular normal saline and up to 21 days of
oral nimodipine capsules or tablets. The primary outcome measure is
the proportion of patients with a favorable outcome of six to eight
on the Extended Glasgow Outcome Scale (GOSE) at the Day 90 visit.
Additional measures are neurocognitive outcome at Day 90 assessed
by the Montreal Cognitive Assessment (MoCA), safety (including
delayed cerebral infarction at day 30) and health economic
endpoints.
About EG-1962
EG-1962 is a novel polymeric microparticle containing nimodipine
suspended in a diluent of sodium hyaluronate. EG-1962 utilizes
Edge’s proprietary Precisa™ development platform and is
designed to improve patient outcomes following aSAH. EG-1962,
administered through an external ventricular drain (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 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 EVD, 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 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 and Media Contact:Gregory
GinEdge Therapeutics, Inc.Tel: 1-800-208 EDGE (3343)Email:
ggin@edgetherapeutics.com
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