Edge Therapeutics Provides Update following Interim Analysis of Phase 3 NEWTON 2 Study of EG-1962 in Aneurysmal Subarachnoid ...
28 Mars 2018 - 1:00PM
Study Unlikely To Achieve Primary Efficacy
Endpoint; DMC Recommends Discontinuation of Study
Edge Therapeutics, Inc. (Nasdaq:EDGE) today announced that a
pre-specified interim analysis performed on data from the Day 90
visit of the first 210 subjects randomized and treated in the Phase
3 NEWTON 2 study of EG-1962 in adults with aneurysmal subarachnoid
hemorrhage (aSAH) demonstrated a low probability of achieving a
statistically-significant difference compared to the standard of
care in the study’s primary endpoint, if the study is fully
enrolled.
The independent Data Monitoring Committee (DMC) recommended that
the study be stopped based on its conclusion that the study has a
low probability of meeting its primary endpoint. Favorable outcome
was defined as a score of 6 to 8 on the extended Glasgow Outcome
Scale, or GOSE, at Day 90. The DMC also reported that there were no
safety concerns attributed to EG-1962.
Based on the DMC recommendation, Edge has decided to discontinue
the NEWTON 2 study and has taken steps to notify health authorities
and clinical investigators participating in the study. Edge will
perform analyses of the cumulative unblinded data from the NEWTON 2
study to better understand the basis for this outcome.
“We are very disappointed that the NEWTON 2 study did not
demonstrate evidence of improved outcomes with EG-1962, given the
positive findings demonstrated on this measure in our randomized,
open-label Phase 1/2 NEWTON study of EG-1962 in a similar patient
population,” said Brian A. Leuthner, Edge’s President and Chief
Executive Officer.
“We are grateful for the support and commitment from the
participating patients, their families, study investigators and
their teams, and the aSAH community,” said Dr. R. Loch Macdonald,
Edge’s Chief Scientific Officer.
Edge will assess the next steps for the company, but anticipates
in the near term reducing the scope of its operations, including
the size of its workforce, in order to preserve its cash resources,
which were $88.1 million as of December 31, 2017.
Conference Call Details
Edge will host a conference call and webcast today, Wednesday,
March 28, 2018 at 9:00 am Eastern time to discuss the information
contained in this press release. Please dial (877) 388-5691, or
(562) 350-0788 for international callers, and reference conference
ID 7056209 approximately 15 minutes prior to the call. A replay of
the call may be accessed through April 4, 2018 on the investor
section of Edge’s website or by dialing (855) 859-2056, or (404)
537-3406 for international callers, and referencing conference ID
7056209. A live webcast of the conference call will be available on
the investor relations section of Edge’s website at
www.edgetherapeutics.com.
About the NEWTON 2 Study
The Phase 3 NEWTON 2 study compared the efficacy and safety of
EG-1962 (nimodipine microparticles) to standard of care oral
nimodipine in adult patients with aneurysmal subarachnoid
hemorrhage (aSAH). Patients in the experimental arm received 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 received a single dose of intraventricular
normal saline and up to 21 days of oral nimodipine capsules or
tablets. The primary outcome measure was the proportion of patients
with a favorable outcome of 6 to 8 on the Extended Glasgow Outcome
Scale (GOSE) at the Day 90 visit. Additional measures were
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 designed to be
administered through an external ventricular drain (EVD). EG-1962
utilizes Edge’s proprietary Precisa™ development platform and was
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 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 conditions.
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 and plans to
assess and undertake next steps for the company. 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 Gin
Edge Therapeutics, Inc.
Tel: 1-800-208 EDGE (3343)
Email: ggin@edgetherapeutics.com
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