Our lead product candidate, NP001, is a novel, proprietary investigational therapy that regulates activated macrophages associated with chronic neurologic diseases including amyotrophic lateral sclerosis (ALS), Frontotemporal Dementia (FD), and Alzheimer’s disease (AD). NP001 transforms these activated, inflammatory macrophages that are linked to neuronal damage, back to their normal, non-inflammatory state.
Neuraltus demonstrated the ability of NP001 to significantly reduce macrophage activation and the production of inflammatory substances in laboratory models. Administration of NP001 in the most accepted animal model of ALS significantly extended survival.
In Phase 1, NP001 dose-dependently reduced inflammatory macrophages in a study of 32 ALS patients. In the first Phase 2 safety, tolerability and preliminary efficacy study enrolling 136 patients, NP001 demonstrated a 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.
NP001 is a highly purified, intravenous formulation of sodium chlorite, and 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.