Aevi Genomic Medicine Announces Completion of Enrollment for Phase 2/3 SAGA Clinical Trial of AEVI-001 (NFC-1) in mGluR+ ADHD Adolescents
PHILADELPHIA, PA--(Marketwired - Jan 4, 2017) - Aevi Genomic Medicine, Inc. (NASDAQ: GNMX)
- Top-line results expected in Q1 2017
Aevi Genomic Medicine, Inc. (NASDAQ: GNMX) (the Company) announced today that enrollment is complete in the SAGA (Study of Adolescent Glutamate Receptor Network Copy Number Variant ADHD) trial.
All ongoing patients are expected to continue through the follow-up period in order to complete the study. The Company anticipates announcing top-line results during the first quarter of 2017.
"The completion of enrollment in our Phase 2/3 efficacy study for AEVI-001 represents a critical milestone for the Company and demonstrates our capability to translate genomic discoveries into late-stage clinical development programs," said Mike Cola, President and Chief Executive Officer. "We would like to express our gratitude to the patients and clinical sites that are participating in this study, as well as to our colleagues for their commitment and dedication to this critical and potentially groundbreaking clinical trial. We look forward to announcing top-line results later in the quarter."
About the SAGA Trial
The purpose of this multicenter, dose-optimized trial in adolescents with ADHD is to confirm the results from the Phase 1b GREAT study. The trial is designed as a randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 study of AEVI-001 versus placebo in adolescent patients with ADHD who have genetic disorders impacting the mGluR network. The trial enrolled patients between the ages of 12-to-17 years old. The primary and secondary endpoints in the trial are the change from baseline in the ADHD-rating scale Version 5 (ADHD-RS-5) Total Score and the percentage of subjects who respond as determined by the Clinical Global Impression of Improvement (CGI-I). Patients have been randomized 1:1 to receive either a six-week course of AEVI-001 or placebo, with a one-week follow-up. Patients were enrolled from sites that participated in the recent phenotype/genotype study. More information on the SAGA trial is available at www.ClinicalTrials.gov (Identifier: NCT02777931).
About Aevi Genomic Medicine, Inc.
Aevi Genomics 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).
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