Alcobra Presents Positive Results From PhaseIIb MDX Study In Adults With PI-ADHD

(RTTNews) - Alcobra Ltd. (ADHD) announced the presentation of data from a successful Phase IIb study of its proprietary drug candidate MDX or Metadoxine Extended Release in adults with Predominantly Inattentive ADHD or PI-ADHD at the 167th Annual Meeting of the American Psychiatric Association or APA.

The company noted that results from this study showed that MDX provided significant benefit for adults with PI-ADHD after one dose and was as well tolerated as placebo, suggesting that it could eventually offer an attractive non-scheduled treatment option. Evidence of a preferential effect of MDX in this patient population further distinguishes it from conventional stimulant and non-stimulant medications.

This Phase IIb randomized, double-blind, placebo-controlled, cross-over, single center study enrolled 36 adult patients (18 to 55 years old) with diagnosed PI-ADHD. Eligible subjects were randomly assigned in a 1:1:1 ratio to one of three treatment sequences that varied the order of investigational product administration.

In each sequence, subjects received a single dose, approximately one week apart, of MDX 1400 mg, MDX 700 mg, and placebo. The primary endpoint of the study was the mean change from baseline of the Test of Variable of Attention or TOVA ADHD Score.

The TOVA is a computerized continuous performance test or CPT that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation.

According to the company, there were no serious adverse events or any meaningful differences in adverse events profiles between the drug and placebo groups. The most common treatment emergent adverse events (TEAEs) during the active treatment period were fatigue and headache. All adverse events were mild except for three reports of moderate headache. No clinically significant abnormalities in laboratory values, vital sign measurements, ECG parameters, or findings at clinical examination were observed.

The company said it is moving forward with a Phase III trial in adults with ADHD, based on these results and the successful outcome of a prior Phase II placebo-controlled study of MDX.

The study is expected to be completed in the second half of 2014.