Aevi Genomic Medicine has completed patient enrolment for Part B of its ASCEND clinical trial.
The Phase II study will evaluate the safety and efficacy of AEVI-001 in pediatric and adolescent patients with attention deficit hyperactivity disorder (ADHD).
The adaptive, six-week, genomically guided trial comprises parts A and B.
Part A of the trial will investigate a mGluR mutation positive genetic subset of paediatric and adolescent patients, while Part B will examine paediatric and adolescent patients with ADHD without metabotropic glutamate receptor (mGluR) mutations.
In August, Aevi completed enrolling patients for Part A, which features subjects who have one of the eight specific gene mutations implicated in glutamatergic signalling and neuronal connectivity.
Part B includes patients who do not have copy number variants (CNVs) in any of the specific gene mutation(s) implicated in glutamatergic signalling and neuronal connectivity.
The subjects are expected to be randomised in 1:1 ratio into one of two treatment groups, AEVI-001 or placebo.
Topline results from Parts A and B of Aevi's ASCEND trial are scheduled to be available by January next year.
The company plans to conduct individual and pooled analysis for both parts simultaneously, and will provide data on the design of a planned Phase III programme.
Aevi Genomic Medicine chief scientific officer Garry Neil said: “Attention deficit hyperactivity disorder affects millions of paediatric 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.”
AEVI-001 contains improved pharmacokinetic and metabolic profiles, and crosses the blood brain barrier.
The investigational product is yet to receive approval from the US Food and Drug Administration, or any other regulatory agencies.