Aevi Genomic Medicine Announces Completion of Enrollment for Part B of the ASCEND Trial
- 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
- 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
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.
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
AEVI-001 is an investigational agent that has not been approved by the
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
About Aevi Genomic Medicine, Inc.
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