SOURCE: Medgenics, Inc.

Medgenics, Inc.

June 17, 2016 08:00 ET

Medgenics Announces Enrollment of First Patient in Phase 2/3 Clinical Trial of NFC-1 in Adolescents With mGluR Mutation Positive ADHD

PHILADELPHIA, PA--(Marketwired - Jun 17, 2016) - Medgenics, Inc. (NYSE: MDGN) today announced the enrollment of the first patient into the SAGA (Study of Adolescent Glutamate Receptor Network Copy Number Variant ADHD) trial -- a Phase 2/3 clinical trial to evaluate adolescent patients with mGluR mutation positive (mGluR+) attention deficit disorder (ADHD). 

"Enrollment of our first patient is a critical milestone for Medgenics, as it brings us one step closer to offering an innovative precision therapeutic for ADHD patients with mGluR network mutations," said Garry Neil, Chief Scientific Officer. "Furthermore, it demonstrates the strength of our development capabilities, building off the extraordinary response to our phenotype/genotype study. We look forward to completing the study and sharing topline data later this year."

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 NFC-1 versus placebo in adolescent patients with ADHD who have genetic disorders impacting the mGluR network. The trial will enroll 90 patients between the ages of 12-to-17 years old. The primary and key secondary endpoints in the trial will be the change from baseline in the ADHD-rating scale Total Score (ADHD-RS-5) and change from baseline in Clinical Global Impression - Global Improvement Scale (CGI-I). Patients will be randomized 1:1 to receive either a six-week course of NFC-1 or placebo, with a one-week follow-up. Patients will be enrolled from the same 25 sites that were used in the recent phenotype/genotype study. More information on the SAGA trial is available at www.ClinicalTrials.gov (Identifier: NCT02777931). 

About Medgenics

Medgenics is dedicated to unlocking the potential of genomic medicine to identify and treat patients with life-altering conditions. Its efforts, including its internal research and development and ongoing sponsored research and licensing agreements with a well-respected pediatric academic medical center, give Medgenics the ability to focus on the underlying genetic pathway of pediatric diseases with the goal of finding therapeutic solutions for subpopulations of both children and adults living with rare and other difficult-to-treat diseases. Medgenics is also the developer of TARGT™ (Transduced Autologous Restorative Gene Therapy), a proprietary gene therapy platform. For more information, visit the Company's website at www.medgenics.com.

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