PHILADELPHIA, July 19, 2018 /PRNewswire/ -- Aevi Genomic
Medicine, Inc. (NASDAQ: GNMX) (the Company) today announced
that it received positive feedback from the United States Food and
Drug Administration (FDA) on an improved version of the Company's
lead development molecule, AEVI-001, identified as AEVI-004.
Following 2016 U.S. Food and Drug Administration (the FDA)
regulatory guidance on co-crystalization of active drugs, the
Company created a co-crystal of fasoracetam (AEVI-001) with
enhanced physical and chemical properties. The new molecule,
AEVI-004, has comparatively greater stability and a higher melting
point than AEVI-001. The molecule was engineered to maintain
solubility, dissolution and pharmacokinetics substantially similar
to AEVI-001.
The Company has received feedback from the FDA
provisionally indicating that AEVI-004 is a co-crystal of AEVI-001
and a novel drug substance. The FDA also provisionally
indicated that existing toxicology and pathology studies can
support clinical development with AEVI-004.
Assuming positive results from the ongoing Phase 2 ASCEND
clinical trial, and following minimal bridging preclinical and
clinical pharmacological studies requested by FDA, the Company
anticipates progressing the molecule directly into Phase 3 studies
with minimal impact on the program timeline.
AEVI-004 is expected to have composition of matter patents
extending to 2039 and should be listed as a novel drug substance in
the FDA Orange Book.
"The successful engineering of the co-crystal
molecule AEVI-004 provides great flexibility in the further
development of fasoracetam for ADHD and other glutamate
receptor-linked neuropsychiatric diseases,"
said Garry A. Neil, M.D.,
Chief Scientific Officer of the Company. "We are
proud of the work done by our R&D team to develop AEVI-004, and
we will continue to work closely with the FDA as we look to
progress this molecule into Phase 3 studies. We look forward
to presenting topline data from the ongoing Phase 2 ASCEND trial in
the fourth quarter of this year."
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-001 is being developed 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 United States, the Center for
Disease Control 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-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.
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 at
The Children's Hospital of Philadelphia. Based on discoveries
from the genomics collaboration, the Company currently has two
programs in clinical development, AEVI-001 for mGLuR+ ADHD and
AEVI-002 for severe pediatric onset Crohn's disease.
More information on the Company and pipeline is located on
its website www.aevigenomics.com
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 expected
timing of the closing of the private placement, the Company's
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
+1-339-970-2843
Chris.brinzey@westwicke.com
MEDIA INQUIRIES:
FTI Consulting
Irma
Gomez-Dib
+1-212-850-5761
+1-415-706-9155
http://irma.gomez-dib@fticonsulting.com
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SOURCE Aevi Genomic Medicine, Inc.