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NeuroSearch reports positive results from a Phase II study with ABT-894, a neuronal nicotinic receptor (NNR) modulator, for the treatment of adults suffering from Attention-Deficit Hyperactivity Disorder (ADHD)
Ballerup, Denmark | June 20, 2008 | NeuroSearch reports positive results from a Phase II study with ABT-894, a neuronal nicotinic receptor (NNR) modulator, for the treatment of adults suffering from Attention-Deficit Hyperactivity Disorder (ADHD). The Phase II study was a randomised, double-blind, and placebo-controlled dose-ranging study to evaluate the efficacy and safety of ABT-894 in approximately 200 adults with ADHD, and with atomoxetine (Strattera(R)) as active control. The ABT-894 compound was discovered by a joint scientific team from NeuroSearch and Abbott under collaboration between the two companies.
Results from the Phase II study show that ABT-894 was efficacious in adult ADHD measured as a statistically significant improvement on the primary endpoint; the total score of the Conners’ Adult ADHD Rating Scales (CAARS). ABT-894 and atomoxetine appeared to be comparable across efficacy measures. In the study, ABT-894 was safe and generally well tolerated and demonstrated statistically significant efficacy compared to placebo in adults suffering from ADHD.
Flemming Pedersen, CEO in NeuroSearch comments:
“We are very pleased by the positive results seen in this Phase II adult ADHD study with ABT-894 and excited about the prospects for this compound as a potential new treatment of ADHD. The portfolio of compounds in development under our collaboration with Abbott has broad potential in several central nervous system disorders, and we are highly satisfied with its progress”.
ABT-894 is an NNR agonist, which targets the a4b2 NNR subtype. The compound has demonstrated efficacy in multiple preclinical animal models of central nervous system disorders including neuropathic pain and nociceptive pain with and without an inflammatory component, and has been evaluated in extensive clinical Phase I single- and multi-dose studies, including studies with markers for cognitive improvements. ABT-894 also is currently in a Phase II study for neuropathic pain where patient enrolment is ongoing.
ADHD is a common neurobehavioral disorder of childhood with an estimated prevalence of approximately 7.8% among children between 4 and 17 of age. Very often the disorder persists into adulthood, and approximately 4.7% of adults are estimated to suffer from ADHD. The principal symptoms of ADHD are inattention, hyperactivity, andimpulsivity to a degree where the patients are at high risk for ongoing emotional and behavioral problems as well as impaired functioning across social, familial, and educational/employment settings. Currently available ADHD medications are generally associated with multiple side-effects and there is a high need for new, both efficacious and safer treatment options.
The positive results from the Phase II study with ABT-894 in adult ADHD do not change NeuroSearch’s financial expectations for 2008 of an operational loss in the region of DKK 450 million.
SOURCE: NeuroSearch |
