logo
Share SHARE
FONT-SIZE Plus   Neg

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

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
We urge Investors to take advantage of the weakness in the shares of Applied Optoelectronics, Inc. (AAOI), as we believe the stock has at least 15% upside from current levels. The stock is down along with many of the stocks in the Fiber optical component universe with an exposure to China. Nestle SA's shares were gaining around 4 percent in Zurich trading after billionaire activist investor Daniel Loeb's hedge fund Third Point LLC bought a $3.5 billion stake in the Swiss food giant. The acquisition of about 1.25% stake in Nestle would put pressure on the company to find ways to accelerate growth. We believe this stock is well-positioned for at least 15% upside from current $23 levels. The stock featured on our premium product Short-Term Investor on April 25 at an opening price of $19.5, and on June 9 touched an intra-day high of $29.73, returning a gain of 52.4% to investors. It is now at an attractive price point again.
comments powered by Disqus
Follow RTT