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

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