Alcobra Ltd. (ADHD) announced on Monday that its proprietary non-stimulant drug candidate, Metadoxine ER (MG01CI), delivered statistically positive results in a phase 2b clinical trial in adults with Predominately Inattentive ADHD (PI-ADHD). Last week we suggested that PropThink Premium subscribers buy ADHD ahead of these trial results, noting that the $16-range was an attractive entry point. The positive trial results (and timing) were not particularly surprising to the markets, hence the stock’s muted reaction.
There are three components used to describe and diagnose ADHD – distractibility, impulsiveness and hyperactivity. PI-ADHD is similar to the other types of ADHD except that individuals with the condition generally don’t exhibit symptoms such as hyperactivity or impulsiveness.
This phase 2b was a randomized, double-blind, placebo-controlled study that enrolled 36 adults with PI-ADHD. 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 at 1400mg, MG01CI at 700mg and placebo. The primary outcome was change from baseline in the Test of Variables of Attention (TOVA) ADHD score. 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.
The study demonstrated a statistically significant change from baseline for MG01CI 1400mg 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 1400mg compared with placebo on the TOVA sub-score of reaction time variability (mean change 7.9, SD 19.2, p=.022). The study found a statistically significant change from baseline for MG01CI 1400 mg compared with the 700 mg dose on the TOVA ADHD score (mean change 1.8, SD 4.7, p=.032). The company will present complete results on December 20, 2013.
ADHD is often considered a “garbage pail” diagnosis for children (particularly boys) who have behavioral and cognitive issues in school. In addition, there is growing opposition from practitioners who believe that currently available drugs are being overprescribed to patients who do not meet the accepted criteria for ADHD. Practitioners point to the “stimulant” nature of many approved treatments and the potential for abuse. While approved stimulant medications have been shown to be effective and safe for the treatment of ADHD, 30% to 50% of those who are prescribed stimulants for ADHD either do not respond to or do not tolerate these treatments. A New York Times article this weekend highlighted this “overprescribing” phenomenon.
As a non-stimulant approach to the treatment of ADHD, MG01C1 could hold some unique advantages over current therapies – particularly if patients face greater restrictions on ADHD medications and diagnoses in the near future.
TADHD is inexpensive at $200M and has a pivotal 2014 with the completion of two large phase 3 trials in the second half. We expect the stock to continue to gain attention as those readouts approach, and will have a more detailed report on ADHD in the next quarter. In the past, we’ve expressed concern about Alcobra’s ability to protect the asset (intellectual property), but have since become more comfortable as we’ve evaluated the existing IP estate and exclusivity opportunities. Alcobra remains a top interest at PropThink for 2014.
In connection with ADHD, PropThink has taken a long position.
