PHILADELPHIA, Aug. 14, 2018 /PRNewswire/ -- Aevi
Genomic Medicine, Inc. (NASDAQ: GNMX) (the Company) today
announced that it has completed enrollment in Part A (n=64) of its
Phase 2 ASCEND clinical trial, which is assessing a mGluR mutation
positive genetic subset of pediatric and adolescent patients with
Attention Deficit Hyperactivity Disorder (ADHD), to confirm
response to AEVI-001 in these patients.
"We are pleased that we have completed enrollment in Part A of
our ASCEND trial" said Garry A.
Neil, M.D., Chief Scientific Officer of Aevi Genomic
Medicine. "This milestone brings us one step closer to evaluating
the impact of AEVI-001 in mGluR+ ADHD patients and we look forward
to announcing topline data for Part A of ASCEND in the fourth
quarter of this year."
About the ASCEND Clinical Trial
ASCEND is an adaptive, 6-week, double-blind parallel-group study
in children and adolescents (ages 6-17 years) with ADHD with and
without copy number variants (CNVs) in specific genes implicated in
glutamatergic signaling and neuronal connectivity. Part A includes
subjects determined to have one of eight specific gene mutation(s)
implicated in glutamatergic signaling and neuronal
connectivity. Part B will assess subjects who do not have
CNVs in any of the specific gene mutation(s) implicated in
glutamatergic signaling and neuronal connectivity. Once
subjects are confirmed as eligible for each part of the study, they
are randomized to one of two treatment groups (AEVI-001 or placebo)
in a 1:1 ratio.
About AEVI-001
AEVI-001 is an oral non-stimulant pan selective
activator/modulator of mGluRs. The molecule has excellent
pharmacokinetic and metabolic profiles and crosses the blood brain
barrier.
Aevi Genomic Medicine is developing AEVI-001 as a potential
treatment for a sub-population of Attention Deficit Hyperactivity
Disorder (ADHD) patients with genetic mutations that disrupt the
mGluR network. In the US, the CDC estimates that 6.4 million
children 4-17 years of age (11%) have ever been diagnosed with
ADHD. Many ADHD patients remain unsatisfied with existing
therapies, particularly with respect to safety, tolerability and
treatment of comorbidities.
AEVI-001 is an investigational agent that has not been approved
by the US FDA or any other regulatory agencies.
About Aevi Genomic Medicine, Inc.
Aevi Genomic Medicine, Inc. is dedicated to unlocking the
potential of genomic medicine to translate genetic discoveries into
novel therapies. Driven by a commitment to patients with pediatric
onset life-altering diseases, the Company's research and
development efforts leverage an internal genomics platform and an
ongoing collaboration with the Center for Applied Genomics (CAG) at
The Children's Hospital of Philadelphia (CHOP).
Forward-looking Statements
This release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and as that term is defined
in the Private Securities Litigation Reform Act of 1995, which
include all statements other than statements of historical fact,
including (without limitation) those regarding the Company's
financial position, status and timing of clinical trials, its development and
business strategy, its product candidates and the plans and
objectives of management for future operations. The Company intends
that such forward-looking statements be subject to the safe harbors
created by such laws. Forward-looking statements are sometimes
identified by their use of the terms and phrases such as
"estimate," "project," "intend," "forecast," "anticipate," "plan,"
"planning, "expect," "believe," "will," "will likely," "should,"
"could," "would," "may" or the negative of such terms and other
comparable terminology. All such forward-looking statements are
based on current expectations and are subject to risks and
uncertainties. Should any of these risks or uncertainties
materialize, or should any of the Company's assumptions prove
incorrect, actual results may differ materially from those included
within these forward-looking statements. Accordingly, no undue
reliance should be placed on these forward-looking statements,
which speak only as of the date made. The Company expressly
disclaims any obligation or undertaking to disseminate any updates
or revisions to any forward-looking statements contained herein to
reflect any change in the Company's expectations with regard
thereto or any change in events, conditions or circumstances on
which any such statements are based. As a result of these factors,
the events described in the forward-looking statements contained in
this release may not occur.
CONTACT:
Aevi Genomic Medicine, Inc.
Brian Piper
Brian.Piper@aevigenomics.com
Westwicke Partners
Chris Brinzey
339-970-2843
Chris.Brinzey@westwicke.com
MEDIA INQUIRIES:
FTI Consulting
Irma Gomez-Dib
+1212-850-5761
+1-415-706-9155
irma.gomez-dib@fticonsulting.com
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SOURCE Aevi Genomic Medicine, Inc.