Alcobra shares slide as its only drug misses main Phase II goal in fragile X syndrome

The only drug in the pipeline of Israeli pharma company Alcobra (Nasdaq: ADHD) has failed in a Phase II trial, causing shares to fall as much as 28.5% to $6.00 in pre-market trading on Wednesday, although they closed the day down just 13% at $7.30.

Alcobra's experimental fragile X syndrome drug, MG01CI (metadoxine extended release), failed to meet the primary endpoint of a mid-stage trial. Patients with fragile X syndrome were randomized to be treated with either metadoxine or placebo, while some patients were simultaneously treated with a psychotropic drug or approved treatment for attention deficit-hyperactivity disorder.

There was no significant difference between the treatment groups when considering the main goal, which was the change from baseline to week six of the inattentive subscale of the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV). The result, in fact, favored placebo. It also failed to improve the ADHD RS score or the Clinical Global Impression score versus placebo, and no benefits were observed on the Aberrant Behavior Checklist or Repeatable Battery for the Assessment of Neuropsychological Status List Learning test.