SOURCE: Aevi Genomic Medicine, Inc.

Aevi Genomic Medicine, Inc.

January 04, 2017 08:00 ET

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 (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).

Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

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