- In the two clinical studies, ABT-894 was well tolerated and demonstrated a good safety profile - At the tested doses, ABT-894's effect on pain reduction did not support continued development in neuropathic pain NeuroSearch and Abbott have evaluated ABT-894, an α4β2-specific neuronal nicotinic receptor (NNR) agonist, in a clinical Phase II programme for the treatment of diabetic neuropathic pain. The Phase II programme consisted of two parallel, randomised, double-blinded, and placebo-controlled studies - one of which was also active-controlled, comprising a total of 404 patients suffering from diabetic neuropathic pain. Both studies compared the efficacy and safety of eight-weeks' treatment of different doses of ABT-894 to placebo. One study included duloxetine (Cymbalta®) as an active comparator. The primary endpoint assessed in both Phase II studies was the change in the weekly average pain score as calculated from the subjects' daily pain diary. ABT-894 did not demonstrate an adequate effect in either study. These Phase II efficacy results do not support further development of ABT-894 in neuropathic pain, and the pain programme will be discontinued. Safety results from the pain studies demonstrated a low incidence of adverse events at all ABT-894 dose levels comparable to placebo. Furthermore, there was no indication of consistent heart rate or blood pressure changes compared to placebo at any ABT-894 dose. NeuroSearch and Abbott have also evaluated ABT-894 in a Phase II study in adult ADHD (Attention Deficit Hyperactivity Disorder). Results from this study were disclosed in July 2008. ABT-894 was discovered under a drug discovery collaboration between NeuroSearch and Abbott (1999-2003) in the field of NNR modulators. Apart from ABT-894 in ADHD, the portfolio of NNR products under the continued collaboration with Abbott include also ABT-107 in Phase I development as a potential new treatment for Alzheimer's disease and schizophrenia, as well as ABT-560. NeuroSearch will disclose financial guidance for 2009 in connection with the company's 2008 full year announcement on 4 March 2009. Thomas Hofman-Bang Chairman of the Board Contact persons: Flemming Pedersen, CEO, telephone: +45 2148 0118 Hanne Leth Hillman, Vice President, Director of Investor Relations & Corporate Communications, telephone: +45 4017 5103 NeuroSearch - Company profile NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on Nasdaq OMX Copenhagen. The company's core business covers the development of novel drugs, based on a broad and well-established drug discovery platform focusing on ion channels and CNS disorders. A substantial share of NeuroSearch's activities is partner financed through collaborations with GlaxoSmithKline (GSK), Abbott and Astellas. The drug pipeline comprises 12 clinical (Phase I-III) development programmes: ACR16 for Huntington's disease (Phase III), tesofensine for obesity and in Type 2 diabetes (ready for Phase III), NS2359 for depression (Phase II) and ADHD (Phase II) in partnership with GSK, ABT-894 for ADHD (Phase II) in partnership with Abbott, ACR16 for schizophrenia (Phase I) in partnership with Astellas, ACR325 for Parkinson's disease (Phase II in preparation) and bipolar disorder (Phase II in preparation), ABT-107 and ABT-560 for the treatment of various CNS disorders - both (Phase I) in collaboration with Abbott, ACR343 for Parkinson's disease (Phase I) and NSD-788 for anxiety/depression (Phase I). In addition, NeuroSearch has a broad portfolio of preclinical drug candidates and holds equity interests in several biotech companies.
NeuroSearch announces results from Phase II studies of ABT-894 in diabetic neuropathic pain
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