August 29, 2016 9:59 AM ET


Company Overview of Neuraltus Pharmaceuticals, Inc.

Company Overview

Neuraltus Pharmaceuticals, Inc., a biopharmaceutical company, develops and commercializes therapeutics for use in the treatment of neurodegenerative diseases. It offers NP001, an investigational therapy that regulates activated macrophages associated with chronic neurologic diseases, including amyotrophic lateral sclerosis, Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis. Neuraltus Pharmaceuticals, Inc. was founded in 2004 and is based in Palo Alto, California.

2479 East Bayshore Road

Suite 220

Palo Alto, CA 94303

United States

Founded in 2004





Key Executives for Neuraltus Pharmaceuticals, Inc.

Chief Executive Officer, President and Director
Age: 69
President, Chief Financial Officer and Chief Operating Officer
Age: 54
Age: 70
Co-Founder and Chief Scientific Officer
Acting Chief Medical Officer
Compensation as of Fiscal Year 2016.

Neuraltus Pharmaceuticals, Inc. Key Developments

Neuraltus Pharmaceuticals, Inc. Publishes Phase 2 Results of its NP001 Potential Efficacy and Safety in ALS

Published results from a Phase 2 clinical study demonstrate positive trends in the ability of Neuraltus Pharmaceuticals' NP001 investigational treatment to slow the progression of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease) over a 6-month treatment period. While NP001's slowing of decline in the primary and secondary measures of the study was not statistically significant, clinically meaningful slowing of progression was observed in patients with greater baseline inflammation, such that patients who received the high dose of NP001 (2 mg/kg) achieved a 41% improvement versus placebo. Additionally, the data suggest that NP001 may have a dose-dependent ability to halt ALS progression in a subset of patients exhibiting elevated levels of select inflammation biomarkers. Post hoc analysis of the study showed 25% of patients who received 2 mg/kg NP001 had no progression of disease during the six-month dosing period, compared to 11% in the concurrent placebo group, although it did not reach statistical significance (p=0.22). When matched historical placebo controls were included, the difference versus placebo became statistically significant (p=0.02). In addition, results from the study demonstrated trends of clinical benefit for the 2 mg/kg patient cohort in the change in slope of the ALS Functional Rating Score Revised (ALSFRS-R), and in change from baseline in ALSFRS-R through six months and a joint rank analysis of change of ALSFRS-R adjusted for mortality. NP001 was also found to be generally safe and well tolerated. NP001 is an intravenous investigational therapy that reduces neuroinflammation through regulation of macrophage white blood cells within the central nervous system, which are believed to be associated with the progression of ALS. Most patients in the study who responded to NP001, such as having their progression halted, had an elevated biomarker of inflammation, interleukin-18 (IL-18), and were positive for lipopolysaccharide (LPS) in blood plasma at baseline, both of which are believed to play a role in the progression of ALS.i,ii IL-18 and LPS levels decreased in most patients (80% and 70%, respectively) who responded to treatment with 2mg/kg NP001. Adverse events (AEs) occurred in 96%, 94% and 98v of patients in the 2 mg/kg, 1 mg/kg and placebo groups, respectively. Overall, the majority of AEs were considered typical of those observed in ALS patients, and were not considered to be related to NP001. A higher percentage of patients treated with NP001 reported infusion site pain and dizziness versus placebo (33% (2 mg/kg) and 18% (1 mg/kg) versus 5% for placebo; and 20% and 8% versus 7% for placebo, respectively). Treatment-emergent AEs, or those occurring during or after the first dose and within 30 days after the last dose NP001, were 71% (2 mg/kg) and 57% (1 mg/kg) versus 55% for placebo. Serious adverse events, including eight deaths during the trial, were considered unlikely or unrelated to NP001.

Neuraltus Pharmaceuticals, Inc. Announces Promising Efficacy Results of the Phase 2 Clinical Program of Np001 for the Treatment of Amyotrophic Lateral Sclerosis

Neuraltus Pharmaceuticals, Inc. announced promising efficacy results of the company's Phase 2 clinical program of NP001 for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease) are being highlighted in an oral presentation at the inaugural Summit of the ALS Research Group, being held in Bloomington, Minnesota, September 17-19, 2014. According to a post hoc analysis, administration of a high dose of NP001 (2mg/kg) was associated with a halt in disease progression in 27% of patients, approximately 2.5 times greater than the percentage in patients on placebo (10%). The researchers determined that two major plasma factors -- Interleukin-18 (IL-18) and lipopolysaccharide (LPS), both markers of inflammation -- may differentiate NP001 responders from non-responders. In the analysis, the responder population was shown to have had significantly higher levels of IL-18, a cytokine involved in inflammation-driven cell death, than the non-responders at baseline (p=0.02). Additionally, all NP001 responders had detectable levels of LPS in their plasma, signifying abnormal macrophage function, whereas none of the placebo non-progressors had detectable LPS at baseline. NP001 is a small molecule regulator of inflammatory macrophage activity. Aberrant macrophage activity is believed to be a significant contributor to the pathology underlying ALS. Neuraltus' NP001 is designed to restore the normal functioning of macrophages within the central nervous system. Overall, study efficacy results demonstrated positive trends in the ability of NP001 to slow the rate of disease progression, ranging from 13 to 19% in multiple parameters of clinical benefit, although these pre-defined endpoints did not reach statistical significance. The benefit of NP001 related to the degree of baseline inflammation in patients. Those patients with greater baseline inflammation and who received the high dose of NP001 experienced a 44% greater slope improvement (positive trend did not reach significance, however). Further, NP001 was found to be generally safe and well-tolerated in the study.

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