News Feature | October 8, 2014

Alcobra Posts Positive Phase 3 Results For ADHD Drug

By Estel Grace Masangkay

Alcobra, a pharmaceutical company focused on developing treatments for cognitive disorders, announced positive top line results from the Phase 3 study of Metadoxine Extended Release (MDX) in adult patients with ADHD.

MDX (MG01CI)) is a drug candidate under development for the treatment of cognitive disorders Attention Deficit Hyperactivity Disorder (ADHD), and Fragile X Syndrome. The drug acts as a monoamine-independent modulator of gamma-aminobutyric acid (GABA) and has a mechanism of action that does not directly impact dopamine or norepinephrine.

The drug is being evaluated in a placebo-controlled, randomized Phase 3 trial involving 300 patients. The primary endpoint of the study is Conner's Adult ADHD Rating Scale (CAARS-INV), a clinical measure used to determine the presence and severity of symptoms of ADHD. The trial is being conducted at 18 sites in the U.S. and 2 in Israel, where the company is based.

In the modified Intent To Treat (mITT) population, MDX achieved a statistically significant improvement in patient symptoms versus placebo. Patients in the MDX treatment group registered a mean change of 11.6 from CAARS-INV baseline while those in the placebo group registered a score of 8.7. The drug was also able to impact inattention subscale based on the CAARS-INV. The company reported that patients with predominately inattentive (PI) ADHD and combined type (CT) ADHD also showed improvement with MDX.

Dr. Yaron Daniely, Alcobra's president and CEO, said, “We are encouraged by these findings, as they build upon our Phase 2 studies showing that MDX significantly improved symptoms of ADHD without many of the safety and tolerability issues commonly associated with currently available ADHD medications. We look forward to completing the full analysis on the secondary endpoints in the study and reporting the complete data set in the near future." Dr. Daniely said that the company will work on completing its analysis of the study’s secondary endpoints.

Dr. Jonathan Rubin, Alcobra's CMO, said, “We conducted the mITT analysis after observing the disproportional effect of a few extremely large placebo responses which were inconsistent with what has been reported in previous ADHD trials of MDX or other agents. We plan to take the complete findings of this and other MDX studies to the FDA to determine the next steps on the path to potential regulatory approval for MDX.” Alcobra stated that it will move on to advanced clinical trials of MDS in adolescent patients with ADHD, as well as in adolescents and adults with Fragile X Syndrome. The studies will conclude at the end of the year.

The company said it will reveal the study results at different upcoming scientific and medical conferences in the near future.