Navigation Links
Retrospective Analysis Finds Amyotrophic Lateral Sclerosis Patients with High Serum C-Reactive Protein (CRP) Levels May Respond to Immune Regulators Like NP001
Date:4/3/2017

SAN BRUNO, Calif., April 3, 2017 /PRNewswire/ -- Neuraltus Pharmaceuticals, Inc., a privately-held biopharmaceutical company dedicated to developing innovative therapeutics for neurodegenerative diseases, announced that results from an independent retrospective analysis of three clinical data sets in amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), including NP001 Phase 2 data, have been published in the April online edition of JAMA Neurology. The analysis found a correlation between CRP serum levels and the rate of disease progression in ALS patients. CRP is a biomarker for systemic inflammation and a higher inflammatory state is believed to contribute to the progression of ALS. These findings, which were replicated in an independent cohort of ALS patients identified through a regional population registry, suggest that increased levels of CRP may indicate which patients are more likely to respond to drugs that focus on inflammation, like NP001.

"Our findings mark an important next step in ALS research, as they suggest that ALS patients with elevated systemic inflammation as identified through CRP levels, may progress more rapidly," said Christian Lunetta, MD, lead author, Centro Clinico NeMO (NeuroMuscular Omnicenter), Fondazione Serena Onlu. "Understanding the role of inflammation in disease progression is critical as researchers continue to work on potential treatments for ALS. While additional research is necessary, our retrospective analysis of three separate data sets will help guide the development of investigational therapies, especially those, like NP001, focused on systemic inflammation."

The findings from the retrospective data analysis reinforce the use of CRP as a biomarker and potential indicator of disease progression in individuals with ALS. NP001, an investigative therapy being developed by Neuraltus, is currently enrolling a confirmatory Phase 2 study of ALS patients with elevated levels of inflammation as measured by CRP serum levels.  

"NP001 is a very promising investigational therapy for ALS and other related neurodegenerative diseases," said Rich Casey, chief executive officer, Neuraltus Pharmaceuticals. "We are assessing CRP levels in ALS patients as an indicator of increased inflammation in our ongoing Phase 2 study, and will identify any change in baseline of an individual's function and daily living as measured by the ALSFRS-R.  This approach appears to be supported by the results of the retrospective analysis published in JAMA Neurology, especially the correlation between CRP levels and a patient's ALSFRS-R in the two independent cohorts of ALS patients. We anticipate completing enrollment of our confirmatory Phase 2 study this year with the expectation that the collective data from both Phase 2 studies will inform the regulatory path forward for NP001."

NP001's Ongoing Phase 2 Study Design
Neuraltus is currently enrolling patients in the confirmatory second Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in ALS patients who have evidence of systemic inflammation. Patients will receive either NP001 2mg/kg or placebo over a period of 6 months. The study is designed to evaluate the change from baseline of an individual's ALS Functional Rating Score Revised (ALSFRS-R) during the study. Secondary objectives include a change in pulmonary function as measured by vital capacity readings.

The confirmatory Phase 2 study is being conducted at 20 sites in North America and has enrolled 87 of the study's 120 participants. The Company anticipates completing enrollment of the study during the second quarter of 2017, with data analysis expected in the first quarter of 2018. Further information about the study and clinical centers is available at https://clinicaltrials.gov.

About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease) is a rare and fatal neurodegenerative disease characterized by degeneration of motor neurons in the spinal cord and brain. The cause of the disease is currently unknown, but there is increasing evidence that implicates neuroinflammation with the progression of the disease. It is believed that in people with ALS, there are increased levels of inflammatory (activated) macrophages, a type of white blood cell, resulting in the release of factors in the central nervous system that damage motor neurons. NP001, a regulator of macrophage activation, exerts its effect by converting these activated inflammatory macrophages back to their normal state.

There are approximately 400,000 ALS patients worldwide. There are no existing treatments that meaningfully slow the progression of or stabilize the disease, underscoring the need for new and effective drug therapy.

About Neuraltus Pharmaceuticals, Inc.
Neuraltus Pharmaceuticals, Inc. is a privately-held biopharmaceutical company dedicated to developing and commercializing innovative therapeutics that address critical unmet needs for patients and physicians in the treatment of neurodegenerative diseases. The Company is collaborating with global ALS specialists and seeking input from patient advocacy organizations to help inform the clinical development path and better understand the needs of people affected by the disease.

For more information, please visit www.neuraltus.com.

About Centro Clinico NeMO
NeMO (NEuroMuscular Omnicentre) Clinical Center is a highly specialized Center devoted to take care of people affected by neuromuscular diseases, including Amyotrophic Lateral Sclerosis (ALS), Spinal Muscular Atrophy (SMA) and Muscular Dystrophies. These diseases cause severe disability with a high social impact. They need long and complex therapeutic and clinical care paths and there are not cures for them at the moment. Nowadays in Italy neuromuscular diseases affect 40.000 patients. NeMO Clinical Center is sited in four Italian cities: Milan, Rome, Messina and Arenzano (Genoa).

For more information, please visit www.centrocliniconemo.it

Contact: Edie DeVine, GCI Health
Office: +1 (209) 814-9564

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/retrospective-analysis-finds-amyotrophic-lateral-sclerosis-patients-with-high-serum-c-reactive-protein-crp-levels-may-respond-to-immune-regulators-like-np001-300433547.html


'/>"/>
SOURCE Neuraltus Pharmaceuticals, Inc.
Copyright©2017 PR Newswire.
All rights reserved


Related biology technology :

1. Nabsys Secures $20 Million Series D Financing to Support Launch of Semiconductor-Based Single-Molecule Platform for Genomic Analysis
2. Genomics Data Management Leader Annai Systems Offers Shortcut to Analysis
3. Lucintel's Analysis of Global Catalysts Industry: Chemical and Automobile Industries Play Crucial Role in Growth
4. Greenwood Genetic Center Selects Cartagenia BENCHlab NGS, CNV Solutions for Clinical Data Analysis
5. Antibody Technologies and Attrition Rates -- an industry analysis 2013
6. Infinata Implements “Clear Quality” Initiative to Optimize Reliability and Usability of Data, Reports and Analysis for Biopharma and Wealth Management Solutions
7. Ingenuity Systems and Affymetrix Partner to Eliminate Microarray Expression Analysis Bottleneck
8. Rigaku Publishes New Method for Elemental Analysis of Residual Oil by EDXRF
9. Rigaku Announces New EDXRF Method for Elemental Analysis in Gold Processing
10. China Engineering Plastics Industry will Reach US$5 Million By 2017 - Engineering Plastics Market, Share, Size, Analysis, Market Scale, Competition and Forecast 2013-2017
11. Analysis of 2012 New Drug Application Approvals (NDAs) Shows Bio/Pharma Contract Manufacturers Treading Water
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... ... of a complex biological network, a depiction of a system of linkages and ... Dmitry Korkin, PhD, associate professor of computer science at Worcester Polytechnic Institute (WPI) ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... pharmaceutical and biotechnology industries to improve patient outcomes and quality of life, will ... analytical testing are being attributed to new regulatory requirements for all new drug ...
(Date:10/11/2017)... (PRWEB) , ... October 11, 2017 , ... ComplianceOnline’s Medical ... place on 7th and 8th June 2018 in San Francisco, CA. The Summit brings ... well as several distinguished CEOs, board directors and government officials from around the world ...
(Date:10/11/2017)... ... October 11, 2017 , ... A new study ... in frozen and fresh in vitro fertilization (IVF) transfer cycles. The ... IVF success. , After comparing the results from the fresh and frozen transfer ...
Breaking Biology Technology:
(Date:4/11/2017)... Florida , April 11, 2017 ... a security technology company, announces the appointment of independent Directors ... Bendheim to its Board of Directors, furthering the company,s ... ... of NXT-ID, we look forward to their guidance and benefiting ...
(Date:4/4/2017)... 4, 2017   EyeLock LLC , a leader ... United States Patent and Trademark Office (USPTO) has issued ... linking of an iris image with a face image ... the company,s 45 th issued patent. ... timely given the multi-modal biometric capabilities that have recently ...
(Date:3/29/2017)... 2017  higi, the health IT company that operates ... America , today announced a Series B investment ... EveryMove. The new investment and acquisition accelerates higi,s strategy ... transform population health activities through the collection and workflow ... higi collects and secures data today on behalf of ...
Breaking Biology News(10 mins):