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Aevi: AEVI-001 Trial Fails To Meet Primary Endpoint - Quick Facts

Aevi Genomic Medicine, Inc. (GNMX) reported top-line results from the SAGA trial of AEVI-001 (oral non-stimulant) in adolescents with mGluR mutation positive (mGluR+) ADHD. The company said, although AEVI-001 did not meet the primary endpoint of reduction on the ADHD rating scale compared to placebo, there was an encouraging improvement observed on the inattention subscale. Additionally, in a pre-specified responder analysis of ADHD-RS improvement of 30% or more, AEVI-001 demonstrated a statistically significant and clinically meaningful improvement compared to placebo.

In a second pre-specified responder analysis of Clinical Global Impression of Improvement scale, a key secondary endpoint, AEVI-001 demonstrated a statistically significant and clinically meaningful improvement compared to placebo.

Garry Neil, Chief Scientific Officer at Aevi Genomic Medicine, stated: "There is a clear signal of efficacy and clinical benefit with AEVI-001 at the highest dose. The drug demonstrated a dose-response limited by the maximum dose of 400 mg BID and a favorable safety profile. We remain committed to this program and our genomic approach, as we believe this is an important drug for patients with neuropsychiatric disorders. Moving forward we plan to explore higher doses, a refined genomic biomarker, and study pediatric patients which should enhance the response rates and effect size of AEVI-001. We look forward to discussing these results with the FDA."

by RTT Staff Writer

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