Aevi Genomic Medicine Announces Top-Line Results from Placebo-Controlled ASCEND Trial (Parts A & B) of AEVI-001 in Children with ADHD
"We are very disappointed that the ASCEND trial did not achieve its primary endpoint," said
About Aevi Genomic Medicine, Inc.
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 an investigational agent that has not been approved by the US FDA or any other regulatory agencies.
About the ASCEND Trial
The AEVI-001-ADHD-202 study (ASCEND) was a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in children and adolescents (ages 6-17 years) with attention deficit hyperactivity disorder (ADHD) with and without copy number variants (CNVs) in specific genes implicated in glutamatergic signaling and neuronal connectivity. Part A included subjects determined to have one of 8 specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity. Part B included subjects who did not have CNVs in any of the specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity. Once subjects were confirmed as eligible for each part of the study, they were randomized to one of two treatment groups (AEVI-001 or placebo) in a 1:1 ratio.
In Part A of the study, 69 unique subjects were enrolled. In Part B of the study, 109 unique subjects were enrolled. After screening and washout of prior ADHD therapy, subjects entered a dose optimization phase wherein doses were titrated to a dose up to 400 mg BID. Subjects then entered a maintenance phase with weekly follow-up for up to 6 weeks.
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