Aevi Genomic Medicine Inc. (NASDAQ:GNMX) announced the results of the SAGA trial of AEVI-001 which was carried out in adolescents with mGluR mutation positive.
Encouraging results from the trial
AEVI-001 is a representation of a novel paradigm in the genomic diagnosis and treatment of neuropsychiatric disorders. The mGluR predictive biomarker allowed the study of AEVI-001 in a population of ADHD adolescents having genetic mutations which disrupt the mGluR network leading to glutamate imbalance.
A promising improvement was identified on the inattention sub-scale. This was encouraging even though AEVI-001 was not able to achieve the primary end point of a decrease on the ADHD rating scale unlike placebo.
Better performance compared to placebo
It also recorded a statistically, clinically and significant improvement in a pre-specified responder study of ADHD-RS of more than 30% compared to placebo. 70% of patients administered with AEVI-001 achieved this improvement against 42% who were on placebo (p=0.0067).
Another pre-specified responder study of Clinical Global Impression of Improvement scale (CGI-I) which is a very crucial secondary endpoint, AEVI-001 indicated a significant statistically and clinical helpful improvement unlike placebo. Only 33% of patients on placebo (p=0.0155) indicated commendable improvement while 57% of patients treated with AEVI-001 managed a score of very much improved or much improved.
In the safety analysis, results indicated that AEVI-001 was well tolerated in all doses. Most of the adverse occurrences ranked as mild to moderate severeness. No serious adverse effects were recorded.
Comments from the company representatives
Garry Neil the M.D. and Chief Scientific officer at AEVI Genomic Medicine commented that they may have been disappointed that the SAGA trial failed to record the expected statistical significance on the primary endpoint on the development of ADHD-RS, but they were impressed by the statistically and clinically significant achievements recorded by the ADHD-RS and CGI-I analysis. He went further to state that there is a clear indication of efficacy and clinical benefits of AEVI-001 administered at the highest dose.
The drugs indicated a dose-response that was limited by a favorable safety profile and the maximum dose of 400mg BID. The company is still committed to the program and they believe that the drug is very important for patients suffering from neuropsychiatric disorders.
