Alcobra Ltd. Presents Positive Results From Phase IIb Study of Metadoxine Extended Release (MDX) in Adults With Predominantly...
Monday 5 May 2014
MDX produced statistically significant improvement (p < 0.01) on the primary endpoint compared to placebo
MDX was superior to placebo after a single dose while demonstrating a safety profile comparable to placebo
Second placebo-controlled Phase II study in adults with ADHD to demonstrate the efficacy and tolerability of MDX
Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, today announced the presentation of data from a successful Phase IIb study of its proprietary drug candidate MDX (Metadoxine Extended Release) in adults with Predominantly Inattentive ADHD (PI-ADHD) at the 167th Annual Meeting of the American Psychiatric Association (APA).1
"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," said Iris Manor, M.D., senior lecturer and director of the ADHD unit at Geha Mental Health Center. "Evidence of a preferential effect of MDX in this patient population further distinguishes it from conventional stimulant and non-stimulant medications, and we are very excited to share these data with the ADHD treatment community through this important scientific forum."
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 (TOVA®) ADHD Score. The TOVA is a computerized continuous performance test (CPT) that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation.
As previously announced, the intent-to-treat analysis of the primary endpoint demonstrated a statistically significant change from baseline for a single dose of MDX 1400 mg compared with placebo on the TOVA ADHD Score (mean change 2.0, SD 4.2, p = 0.009). The study also demonstrated a statistically significant change from baseline for MDX 1400 mg compared to placebo on the TOVA sub-score of response time variability (mean change 7.9, SD 19.2, p = 0.022), a sub-score correlated with attention and cognition. In addition, the percentage of responders following a single dose of MDX 1400 mg was significantly greater compared with placebo. There were no significant differences observed between the MDX 700 mg dose and placebo in the primary or secondary efficacy endpoints. Between the two doses of MDX, the 1400 mg dose demonstrated significantly greater improvements (p < .05) than the 700 mg dose on most endpoints.
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.
Based on these results and the successful outcome of a prior Phase II placebo-controlled study of MDX, Alcobra is moving forward with a Phase III trial in adults with ADHD. The study is expected to be completed in the second half of 2014.
