Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation

This is a randomized, double-blind, placebo-controlled study of NP001 in subjects with ALS and evidence of elevated systemic inflammation. Subjects will be allocated (1:1) to NP001 and placebo. Drug or placebo will be given intravenously.

Key Inclusion Criteria:

• Diagnosis of clinically possible, clinically probable (with or without laboratory support), or clinically definite ALS (using the revised El Escorial Criteria)
• Forced vital capacity greater than or equal to 65% of that predicted for age and height
• Onset of ALS-related weakness less than 3 years prior to first dose of study drug
• Plasma high sensitivity C-reactive protein (hs-CRP) concentration of greater than or equal to 0.113 mg/dL at pre-screening/screening
• Stable dose (greater than 30 days) of riluzole if undergoing treatment with this agent
• For females: Not be of childbearing potential or agree to use adequate birth control during the study

Key Exclusion Criteria:

• Life expectancy of less than 6 months
• Tracheotomy or be using ventilatory assistance, including Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)
• Active pulmonary disease
• Gastrostomy
• Stem cell therapy
• Immune modulator therapy or participation in studies of other agents within 12 weeks of pre-screening/screening
• Unstable medical condition other than ALS