Navigation Links
Neuraltus Pharmaceuticals Reports Clinical Results from Phase 1/2 NP002 Study in the Treatment of Dyskinesias Resulting from Levodopa Therapy for Parkinson's Disease

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 cases, statistical superiority of NP002 over placebo were observed in a variety of physician- and patient-rated PD efficacy outcome measures relating to dyskinesias.

Abraham Lieberman, MD, the study's principal investigator and Director of the Muhammad Ali Parkinson's Center, commented, "NP002 represents an innovative approach to a common side effect in treating Parkinson's disease and has opened up new ideas on how to approach dyskinesias.  The early study results of NP002 in patients with Parkinson's show promising trends in reducing dyskinesias and in improving gait.  I am encouraged by these results and believe they provide a key piece in understanding and addressing the mechanism of dyskinesias in many of our patients with Parkinson's disease."

J. William Langston, MD, Founder, CEO and Scientific Director of the Parkinson's Institute, stated, "It's impressive that the NP002 study data were encouraging across several scales used to measure dyskinesias.  In particular, the study showed a significant trend in improvement in the objective UDRS scale and statistically significant results on the PGIC scale, which measures how patients feel overall, suggesting an improvement in quality of life.  We are very excited to see this work progress to Phase 2 trials based on these encouraging data."

Carrolee Barlow, MD, PhD, CSO and CMO of BrainCells, Inc., and scientific advisor to Neuraltus on the NP002 program, stated, "Patients with Parkinson's disease currently have no therapeutic options to address the dyskinesias caused by levodopa treatment.  The clinical study demonstrated a clinically important improvement in dyskinesia symptoms that could be detected by both clinicians and patients.  The data are compelling and provide a breakthrough for this condition."

The Phase 1/2 data are the second clinical program results reported by Neuraltus this week, following announcement of clinical results for NP001, which showed safety, tolerability and statistically significant effects on a biomarker of disease progression in ALS.  Neuraltus is committed to accelerating the development of new drug molecules based on novel biology and representing first-in-class approaches to target indications in neurodegenerative disease where there is substantial unmet medical need.

About Neuraltus Pharmaceuticals, Inc.

Neuraltus Pharmaceuticals, Inc. is a privately held biopharmaceutical company dedicated to developing and commercializing high-impact therapeutics that address critical unmet needs, primarily in the treatment of neurodegenerative diseases.  Neuraltus has three clinical-stage programs in its development pipeline, including potential treatments for Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease), Parkinson's disease and dyskinesias associated with the treatment of Parkinson's disease, Alzheimer's disease, and Multiple Sclerosis, as well as lysosomal storage disorders such as Fabry's disease and Gaucher's disease.  Each of Neuraltus' clinical-stage programs is advancing novel drug molecules that represent new, first-in-class approaches to treating the Company's target disease indications.

Neuraltus began operations in 2009 based on a broadly enabling technology portfolio and intellectual property assembled by the company founders, Ari Azhir, PhD, Neuraltus' Chief Operating Officer; Michael McGrath, MD, PhD, Professor of Laboratory Medicine at the University of California, San Francisco; and Edgar Engleman, MD, Professor of Medicine and Pathology at Stanford University School of Medicine.  In March 2009 Neuraltus closed a $17M Series A financing with leading venture groups Latterell Venture Partners, VantagePoint Venture Partners and Adams Street Partners.

For more information on Neuraltus, please visit

SOURCE Neuraltus Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Neuraltus Pharmaceuticals Awarded $733,437 Under the Qualifying Therapeutic Discovery Projects Grant Program (QTDP)
2. Access Pharmaceuticals Updates MuGard Website With First Patient Testimonial Video
3. Sagent Pharmaceuticals Adds to Its Oncology Portfolio With Launch of Topotecan Hydrochloride for Injection
4. Sagent Pharmaceuticals Announces FDA Approval of Midazolam Injection, USP
5. Inspiration Biopharmaceuticals Treats First Patient in Pivotal Study of OBI-1 for Acquired Hemophilia A
6. Onyx Pharmaceuticals Announces December 2010 Investor Events
7. Endo Pharmaceuticals Holdings Inc. Announces Pricing of Private Offering of Senior Notes
8. Prolong Pharmaceuticals Boosts Executive Team
9. Prism Pharmaceuticals Receives FDA Approval of Ready-to-Use NEXTERONE® (amiodarone HCl) Premixed Injection
10. Access Pharmaceuticals ProLindac™ and CobaCyte™ Oncology Research Displayed at the Innovations in Cancer Prevention and Research Conference, November 17-19, 2010
11. Fast Forward, LLC and Provid Pharmaceuticals Announce Expansion of their Partnership for the Development of PV-267, Provids Unique MS Drug Candidate
Post Your Comments:
(Date:11/30/2015)... Asia,s largest exhibition and conference dedicated to the Medical ...  - 22 nd April 2016. --> --> ... --> -->   --> ... aging population and the government back up, the Medical Device is one of ... States . With the aging population and the government back up, the ...
(Date:11/30/2015)... 30, 2015 Nevro Corp. (NYSE: NVRO ), ... solutions for the treatment of chronic pain, today announced that ... Patent and Trademark Office (USPTO) has denied instituting an ... (the ,102 patent).  --> ... Scientific Corporation filed two petitions challenging the validity of certain ...
(Date:11/30/2015)... , Nov. 30, 2015 ... of the "Orphan Drugs Market 2015-2019" ... ) has announced the addition of the ... offering. --> Research and Markets ( ... "Orphan Drugs Market 2015-2019" report to ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... The Museum of Science & ... a new era of publicly accessible automated technology. Now, by popular demand, the ... guests an up-close look at the shuttle at MOSI’s main entrance. This experience ...
(Date:11/30/2015)... ... November 30, 2015 , ... The presidential race normally deals ... So why is it a national news story when Donald Trump makes disparaging remarks ... because appearances count more than anyone wants to admit when it comes to how ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... course in Dallas, TX, on January 29 and 30, 2016. The course welcomes ... functions of their practices, to learn how to better succeed in the modern ...
(Date:11/30/2015)... Georgia (PRWEB) , ... November 30, 2015 , ... ... of a key disease-causing component of bacteria could be effective in fighting methicillin-resistant ... at Georgia State University. , Their study showed that small molecule analogs that ...
(Date:11/30/2015)... ... November 30, 2015 , ... Dr. Seth D. Margulies specializes in orthodontics ... visit Dr. Margulies to experience the best available orthodontic experience in the area. ... Top Dentist"! , Orthodontics is the branch of dentistry that specializes in the diagnosis, ...
Breaking Medicine News(10 mins):