Medgenics has announced the enrollment of the first patient into the SAGA (Study of Adolescent Glutamate Receptor Network Copy Number Variant ADHD) trial—a phase II/III 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."
The purpose of the multicenter, dose-optimized trial in adolescents with ADHD is to confirm the results from the phase Ib GREAT study. The trial is designed as a randomized, double-blind, placebo-controlled, parallel-group phase II/III 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.