PHILADELPHIA, Oct. 15, 2018 /PRNewswire/ -- Aevi
Genomic Medicine, Inc. (NASDAQ: GNMX) (the Company) today
announced that it has reached full enrollment of Part B of its
Phase 2 ASCEND clinical trial. The ASCEND trial is a
genomically-guided study in pediatric and adolescent patients with
Attention Deficit Hyperactivity Disorder (ADHD) assessing the
safety and efficacy of AEVI-001, a novel, non-stimulant
therapy.
- Part B of the ASCEND trial is studying pediatric and adolescent
patients with ADHD without mGluR mutations.
- Part A of the ASCEND trial is studying a mGluR mutation
positive genetic subset of pediatric and adolescent patients.
Part A completed enrollment in August 2018.
- The accelerated enrollment in Part B will allow the Company to
provide complete top line data for both Parts A and B of the ASCEND
trial in January 2019.
- Individual and pooled analysis of Parts A and B will be
conducted simultaneously, and will inform the design of the planned
Phase 3 program.
"We are pleased that we were able to complete enrollment of Part
B so quickly and look forward to presenting the results," said
Garry A. Neil, M.D., Chief
Scientific Officer of the Company. "Attention Deficit
Hyperactivity Disorder affects millions of pediatric and adolescent
patients and despite a number of drugs on the market today, we
believe treatment is suboptimal for many patients. AEVI-001 is a
unique, oral, non-stimulant activator/modulator of mGluRs, with the
potential to help many patients and their families."
Development of AEVI-004, a new chemical entity (NCE), co-crystal
of AEVI-001 continues in order to maximize the value of Part B of
the ASCEND trial. AEVI-004 potentially expands the composition of
matter patent protection through 2039 and broadens market potential
beyond ADHD into other neuropsychiatric diseases.
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.
The Company is developing AEVI-001 as a potential treatment
for a sub-population of Attention Deficit Hyperactivity Disorder
(ADHD) patients with and without genetic mutations that disrupt the
mGluR network. In the United
States, the Center for Disease Control and Prevention
estimates that 6.4 million children 4-17 years of age (11%) have
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 U.S. Food and Drug Administration or any other regulatory
agencies.
About AEVI-004
AEVI-004 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. The molecule is a co-crystal of AEVI-001,
crystallized with a pharmacologically inert conformer with a
favorable toxicological profile. The molecule's
pharmacological properties have been designed, and are expected, to
be very similar to those of AEVI-001. As such, the Company
believes that the molecule may progress directly to phase 3 studies
with only minimal bridging preclinical and clinical pharmacological
studies.
AEVI-004 has several distinct advantages over AEVI-001,
including better stability and better manufacturability owing to a
significantly higher melting point.
AEVI-004 is an investigational agent that has not been approved
by the U.S. Food and Drug Administration 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 and future
financings. 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.