Our lead product candidate, NP001, is a novel, proprietary investigational therapy that regulates inflammatory macrophages associated with chronic neurologic diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD). In the first Phase 2 safety, tolerability and preliminary efficacy study enrolling 136 patients, NP001 demonstrated a potentially clinically relevant slowing of ALS progression in a subset of patients treated over a 6-month period, with a favorable safety and tolerability profile. The most common adverse events were dizziness and injection site pain.
Neuraltus has completed enrollment of a second Phase 2 clinical study of NP001 to confirm the previous Phase 2 findings in ALS patients with elevated levels of baseline inflammation. This second Phase 2 study is a randomized, double-blind, placebo-controlled, multicenter study which has enrolled 138 ALS patients with evidence of systemic inflammation at 22 sites across North America. The last patient visit is expected to occur in early 2018, with top-line results anticipated in the first quarter of 2018. The Company plans to meet with the U.S. Food and Drug Administration (FDA) after the study results are analyzed to review the complete clinical data set and discuss the regulatory path forward for NP001. Further information about the second Phase 2 study of NP001 in ALS patients is available at https://clinicaltrials.gov.
Neuraltus, in partnership with the John A. Burns School of Medicine, University of Hawaii at Manoa, is conducting a Phase 1 placebo-controlled biomarker study of NP001 in patients with mild-to-moderate Alzheimer’s disease. The study is designed to determine the impact of NP001 on the level of systemic inflammation, which is believed to be a contributing factor to disease progression in some neurodegenerative diseases. If the study shows a reduction in inflammation levels, further clinical research may be considered. For more information on the Phase 1 study of NP001 in AD patients, visit https://clinicaltrials.gov.
NP001 is an investigational therapy and the only highly purified, intravenous formulation of sodium chlorite, which is not comparable to oral sodium chlorite. Additional information about oral sodium chlorite, and the potentially dangerous and toxic side-effects which may hasten disease progression, can be found in a warning from the FDA and ALSUntangled article. Neuraltus does not recommend the use of oral sodium chlorite.