Shares of Aevi Genomic Medicine (NASDAQ: GNMX) dropped 60% shortly after market open on news that the company’s AEVI-001 did not meet the primary endpoint of reduction on the ADHD rating scale (ADHD-RS) compared to placebo; however, there was improvement observed on the inattention subscale. The results also show efficacy and benefit to patients in two pre-specified responder analyses: ADHD-RS improvement of 30% or more, which was met by 70% of patients treated with AEVI-001 versus 42% on placebo; and Clinical Global Impression of Improvement scale (CGI-I), resulting in 57% of patients treated with AEVI-001 achieving a score of much improved or very much improved compared to 33% on placebo. “While we are disappointed that the SAGA trial did not achieve statistical significance on the primary endpoint of improvement on ADHD-RS, we are very encouraged by the clinically and statistically significant results we achieved on the ADHD-RS and CGI-I responder analyses,” Aevi Genomic Medicine Chief Scientific Officer Garry Neil, M.D., stated in the news release.
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About Aevi Genomic Medicine, Inc.
Aevi Genomic Medicine, Inc. is dedicated to unlocking the potential of genomic medicine to translate genetic discoveries into novel therapies. Driven by a commitment to patients with pediatric onset life-altering diseases, the company’s research and development efforts leverages an internal genomics platform and an ongoing collaboration with the Center for Applied Genomics (CAG) at The Children’s Hospital of Philadelphia (CHOP). In addition to the AEVI-001 programs, the company is also progressing its second program, AEVI-002 into clinical development for Severe Pediatric Onset Crohn’s Disease. More information on the company and pipeline is located on its website www.aevigenomics.com
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