Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Alcobra Ltd. announced today top-line results from a six week, randomized, placebo-controlled, Phase II multi-center study designed to assess the safety and efficacy of MG01CI in adults with attention deficit hyperactivity disorder (ADHD). Results showed MG01CI met the primary efficacy outcome, demonstrating a significant improvement on the Conners' Adult ADHD Rating Scale-Investigator Rated Total ADHD Symptoms Score (CAARS-INV) compared to placebo (p<0.03).
“These results confirm previous clinical experience indicating MG01CI may have a quick onset of activity with few side effects, distinguishing it from other non-stimulant ADHD treatments”
In the study, 56 percent of subjects treated with MG01CI experienced an improvement in their CAARS-INV score of at least 25 percent, compared to 36 percent of patients in the placebo group (p<0.03). Additionally, 44 percent of the subjects treated with MG01CI demonstrated an improvement of more than 40 percent in their CAARS-INV score versus only 25 percent in the placebo group (p<0.04). MG01CI was well tolerated, with no drug-related serious adverse events reported and no clinically or statistically significant differences in adverse event profiles between the MG01CI and placebo treatment arms. Nausea and initial insomnia were more frequently reported in the MG01CI arm, yet the rate of patient discontinuation due to adverse events was similar in both groups (1.7%). Importantly, no increase in blood pressure or appetite suppression was recorded in the treatment group.
"ADHD is the most commonly studied and diagnosed chronic psychiatric disorder in children and adults, affecting about 3 to 5 percent of the population," said Iris Manor M.D., director of the ADHD Unit, Geha Mental Health Center in Petach Tikva, Israel. "I am very encouraged by the results of this trial, which warrants further clinical development of MG01CI, a novel non-stimulant drug that may benefit many people with ADHD."
In the trial, MGO1CI also demonstrated significant improvement on secondary endpoints, including the Adult ADHD Quality of Life Scale (AAQoL) and the Test of Variables of Attention (T.O.V.A.®) scores.
"We are very pleased with the Phase II data announced today," said Dr. Aharon Schwartz, Head of Teva's Innovative Ventures. "Our collaboration with Alcobra on the development of MG01CI for ADHD complements Teva's focus on developing a portfolio of products within our core specialty area of expertise - neurological disorders."
"These results confirm previous clinical experience indicating MG01CI may have a quick onset of activity with few side effects, distinguishing it from other non-stimulant ADHD treatments," said Dr. Yaron Daniely, CEO of Alcobra. "Based on the positive results of this Phase II trial and the high unmet need for novel ADHD treatments, we intend to commence Phase III studies in adults in 2012 and later on in children."
Following the successful completion of the Phase I study of MG01CI in 2010, Teva took an equity position in Alcobra, in addition to the right to acquire the company in stages up to full ownership upon regulatory approval of MG01CI.
Additional Phase II study results for MG01CI in ADHD are planned to be presented at international scientific meetings later this year.
Teva Pharmaceutical Industries Ltd.