Thinly traded nano cap Aevi Genomic Medicine (GNMX -56.4%) craters on more than a 5x surge in volume in response to its announcement that lead product candidate AEVI-001 failed to beat placebo in its SAGA clinical trial in adolescents with mGluR mutation-positive attention deficit hyperactivity disorder (ADHD). The study did not achieve its primary endpoint of a statistically valid reduction in a rating scale called ADHD-RS.
The company remains hopeful, however, citing an encouraging improvement on the inattention subscale (p=0.0515) and data from a pre-specified analysis of high responders (ADHD-RS improvement of at least 30%) that showed a statistically significant greater proportion AEVI-001-treated patients in this group compared to placebo (70% vs. 42%; p=0.0067). The study also achieved a key secondary endpoint of a statistically valid effect as measured by another scale called CGI-I (57% vs. 33%; p=0.0155).
The company intends to discuss the data with the FDA and presenting the results at the World Congress on ADHD next month.