Aevi Genomic Medicine To Present Updated Results From SAGA Trial Of AEVI-001 At The 6th World Congress On ADHD

PHILADELPHIA, PA--(Marketwired - April 12, 2017) - Aevi Genomic Medicine, Inc. (NASDAQ: GNMX) (the Company) today announced that results identifying a genomic subset of responders from the SAGA trial of AEVI-001 will be presented at the 6th World Congress on ADHD (Attention Deficit Hyperactivity Disorder) taking place April 20-23, 2017 in Vancouver, Canada. In addition, the Company will present findings from a non-interventional phenotype/genotype study of nearly 2,000 children diagnosed with ADHD.

The data will be presented by Garry A. Neil, M.D., Chief Scientific Officer and Liza A. Squires, M.D., Vice President, Head of Neuroscience, during two poster sessions. Details are as follows:

Title: Double-blind placebo-controlled study of the novel therapeutic AEVI-001 in adolescents with ADHD and glutamatergic network gene mutations in children and adolescents with ADHD (SAGA Trial)
Presenter: Garry A. Neil, M.D., Chief Scientific Officer, Aevi Genomic Medicine, Inc.
Date: Friday, April 21, 2017, 14:30-16:00 PDT
Session: Pharmacological treatment of children and adolescents II
Abstract: P-17-001
Location: Exhibition Hall A, Vancouver Convention Centre

Title: Glutamatergic network gene mutations in children and adolescents with ADHD (Phenotype/Genotype Study)
Presenter: Liza A. Squires, M.D., Vice President, Head of Neuroscience, Aevi Genomic Medicine, Inc.
Date: Friday, April 21, 2017, 14:30-16:00 PDTSession: Aetiology II
Abstract: P-02-006
Location: Exhibition Hall A, Vancouver Convention Centre

About AEVI-001

AEVI-001 is an oral non-stimulant pan selective activator/modulator of mGluRs. The molecule has excellent PK and metabolic profiles and crosses the blood brain barrier.

Aevi Genomic Medicine remains committed to the development of AEVI-001 as a potential treatment for a sub-population of Attention Deficit Hyperactivity Disorder (ADHD) patients with genetic mutations that disrupt the mGluR network. The Company will also develop AEVI-001 for the treatment of autism spectrum disorder (ASD) patients with genomically identifiable mutations in the mGluR network. In the US, the CDC estimates that 6.4 million children 4-17 years of age (11%) have ever been diagnosed with ADHD.(1) Many ADHD patients remain unsatisfied with existing therapies, particularly with respect to safety, tolerability and treatment of comorbidities. In the US in 2012, 1 in 68 children were diagnosed with ASD (2012) increasing from 1 in 150 (2000)(2). There is a high unmet need for pharmaceutical treatments for ASD as currently approved medications are indicated for symptoms of irritability in ASD patients.

AEVI-001 is an investigational agent that has not been approved by the US FDA or any other regulatory agencies.

About the SAGA Trial

SAGA was a multicenter, dose-optimized trial in adolescents with ADHD. The trial was designed as a randomized, double-blind, placebo-controlled, parallel-group study of AEVI-001 versus placebo in adolescent patients with ADHD who have genetic disorders impacting the mGluR network. The trial enrolled 101 patients (96 evaluable) between the ages of 12-17 years old. The primary and secondary endpoints in the trial were the change from baseline in the ADHD-Rating Scale Version 5 (ADHD-RS-5) Total Score and the percentage of subjects who responded as determined by the Clinical Global Impression of Improvement (CGI-I), respectively. Patients were 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 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 leverage an internal genomics platform and an ongoing collaboration with the Center for Applied Genomics at The Children’s Hospital of Philadelphia.

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

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.

Sources
(1)https://www.cdc.gov/ncbddd/adhd/data.html
(2)https://www.cdc.gov/ncbddd/autism/data.html