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Neuraltus Pharmaceuticals Reports Clinical Results from Phase 1/2 NP002 Study in the Treatment of Dyskinesias Resulting from Levodopa Therapy for Parkinson's Disease
Date:12/3/2010

PALO ALTO, Calif., Dec. 3, 2010 /PRNewswire/ -- Neuraltus Pharmaceuticals, a privately held biopharmaceutical company dedicated to developing and commercializing high-impact therapeutics that address critical unmet medical needs, primarily for the treatment of neurodegenerative diseases, announced today top-line results from the Company's Phase 1/2 clinical study of NP002 for the treatment of dyskinesias (muscle movement disorders) resulting from levodopa therapy for patients with Parkinson's disease.  Of the 500,000-1.5 million Parkinson's patients in the United States, about 50% experience incidence of levodopa-induced dyskinesias (LIDs), for which there are no approved treatments.  NP002 is a small molecule, orally available nicotinic receptor agonist that has been shown in preclinical studies to reduce LIDs without affecting Parkinsonian symptoms.

A double blinded, placebo controlled, Phase 1/2 study was performed to assess the safety and tolerability of NP002 in a total of 65 individuals with Parkinson's disease and documented LIDs.  The primary objective of the study was the establishment of safety and tolerability of NP002, with patients being assessed over a 14-week treatment and monitoring period.  The secondary objective was to investigate the effects of NP002 on a set of Parkinson's disease and dyskinesia assessment scales, including The Unified Parkinson's Disease Rating Scale (UPDRS), the Unified Dyskinesia Rating Scale (UDRS), the Lang-Fahn Activities of Daily Living Scale (LF-ADL), and the clinician and patient global impressions of change scales (CGIC and PGIC).

NP002 administered concurrently with levodopa treatment was found to be generally safe and well-tolerated in Parkinson's patients with LIDs.  In addition, NP002 was not associated with any impulsivity or withdrawal issues when compared to placebo.  Although the trial was not powered as an efficacy study, clinically relevant trends and, in two cas
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SOURCE Neuraltus Pharmaceuticals, Inc.
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