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AEVI-001 effective for adolescents with ADHD, contactin-4 mutation
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Aevi Genomic Medicine recently presented updated responder data from the SAGA trial of AEVI-001, an oral nonstimulant, for adolescent ADHD.
“The SAGA trial post-hoc responder analysis represents a novel genomic approach to psychiatric drug development,” study researcher Robert L. Findling, MD, MBA, of Johns Hopkins University School of Medicine, said in a press release. “Genetic stratification of patient subpopulations appears to identify patients with specific gene mutations who are more likely to respond to AEVI-001.”
The new analysis included 42 participants with mutations in the contactin-4 (CNTN4) gene and certain GRM and neurodevelopmental genes. Of these, 18 participants received AEVI-001 and 24 received placebo.
Findings indicated that 89% of participants who received AEVI-001 exhibited statistically significant improvement in ADHD-Rating Scale (ADHD-RS) scores, compared with 21% of participants who received placebo.
Participants who received AEVI-001 had a reduction in ADHD-RS scores of 17.6, compared with 5.9 among participants who received placebo (P < .005).
All participants with copy-number variation mutations in CNTN4 (n = 18) who received AEVI-001 (n = 6) had a reduction in ADHD-RS scores of 30% or more, compared with 25% of the placebo group (P = .0027).
Participants with copy-number variation mutations in CNTN4 exhibited a 20.8-point reduction in ADHD-RS scores, compared 8.9 points among those who received placebo (P = .03).
“The robust response of CNTN4 mutation-positive ADHD adolescents to AEVI-001 in the SAGA trial suggests that CNTN4 associated [autism spectrum disorders (ASD)] may be successfully treated with AEVI-001," study researcher Garry A. Neil, MD, chief scientific officer of Aevi Genomic Medicine, said in the release. “Based on these new findings, we are validating the prevalence of CNTN4 mutations in ASD and will further characterize the phenotypes associated with this mutation. Importantly, the company intends to continue the development of AEVI-001 in ADHD and ASD, as well as other potential neuropsychiatric indications in genomically defined populations based on the responder analysis of the SAGA trial.”