Alcobra Ltd., an emerging biopharmaceutical company, has reported highly statistically significant positive results from a phase IIb clinical trial with MG01CI in adults with Predominantly Inattentive Attention Deficit Hyperactivity Disorder (PI-ADHD).
This phase IIb trial was a randomized, double-blind, placebo-controlled, cross-over single center study that enrolled 36 adult subjects with PI-ADHD at Geha Mental Health Centre in Petach Tikva, Israel. 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 treatment sequence, subjects received a single administration, approximately one week apart and in different orders, of MG01CI 1,400 mg, MG01CI 700 mg and placebo. The primary outcome was the change from baseline of the Test of Variables of Attention (TOVA®) ADHD score. The TOVA is a computerized continuous performance test that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation.
In an intent-to-treat analysis of the primary endpoint, the study demonstrated a statistically significant change from baseline for MG01CI 1,400 mg compared with placebo on the TOVA ADHD score (mean change 2.0, SD 4.2, p = .009). The study also demonstrated a statistically significant change from baseline for MG01CI 1,400 mg compared with placebo on the TOVA sub-score of reaction time variability (mean change 7.9, SD 19.2, p=.022). In addition, the study found a statistically significant change from baseline for MG01CI 1,400 mg compared with the 700 mg dose on the TOVA ADHD score (mean change 1.8, SD 4.7, p=.032). There were no serious adverse events or any meaningful differences in adverse events profile between the drug and placebo groups.
Jonathan Rubin, the chief medical officer of Alcobra Ltd, commented, "This study provides confirmation of the immediate effects of a single 1,400 mg dose of MG01CI in adults. The statistical significance and magnitude of effect in this study replicate and confirm the TOVA findings observed in our previous placebo-controlled Phase IIb trial with MG01CI in 120 adults with ADHD. There are now two placebo-controlled Phase II studies that demonstrate the significant efficacy and tolerability attributes of MG01CI in adults with ADHD."
The results from this study will be presented in New York on December 20th at investor event.
The PI-ADHD is characterized by symptoms of inattentiveness. Individuals tend to be easily distracted and forgetful of details of daily routines and typically have problems organizing or finishing tasks, paying attention to details, and/or following instructions or conversations. The PI-ADHD subtype differs from the more commonly recognized combined subtype of ADHD in that symptoms of hyperactivity and impulsivity may be absent or minimal.
Alcobra Ltd. is focused on the development and commercialization of a proprietary drug candidate, MG01CI, to treat cognitive dysfunctions including ADHD and Fragile X Syndrome.