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|Aevi Genomic Medicine to Present Updated Results from SAGA Trial of AEVI-001 at the 6th World Congress on ADHD|
The data will be presented by
Title: Double-blind placebo-controlled study of the novel therapeutic AEVI-001 in adolescents with ADHD and glutamatergic network gene mutations in children and adolescents with ADHD (SAGA Trial)
Title: Glutamatergic network gene mutations in children and adolescents with ADHD (Phenotype/Genotype Study)
AEVI-001 is an oral non-stimulant pan selective activator/modulator of mGluRs. The molecule has excellent PK 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 SAGA Trial
SAGA was a multicenter, dose-optimized trial in adolescents with ADHD. The trial was designed as a randomized, double-blind, placebo-controlled, parallel-group study of AEVI-001 versus placebo in adolescent patients with ADHD who have genetic disorders impacting the mGluR network. The trial enrolled 101 patients (96 evaluable) between the ages of 12-17 years old. The primary and secondary endpoints in the trial were the change from baseline in the ADHD-Rating Scale Version 5 (ADHD-RS-5) Total Score and the percentage of subjects who responded as determined by the Clinical Global Impression of Improvement (CGI-I), respectively. Patients were randomized 1:1 to receive either a six-week course of AEVI-001 or placebo, with a one-week follow-up. Patients were enrolled from sites that participated in the recent phenotype/genotype study. More information on the SAGA trial is available at www.ClinicalTrials.gov (Identifier: NCT02777931).
The Company is also progressing its second program, AEVI-002 into clinical development for Severe Pediatric Onset Crohn's Disease.
More information on the Company and pipeline is located on its website www.aevigenomics.com
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