Aevi Genomic Medicine Announces Completion of Enrollment in Part A of Phase 2 ASCEND Trial in ADHD
PHILADELPHIA, Aug. 14, 2018
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.
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).
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