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), Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis. 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 a Phase 2a 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.