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), Alzheimer’s disease, and Parkinson’s disease. 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 is currently enrolling 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 enrolling up to 120 subjects in North America with ALS and evidence of systemic inflammation. Further information about the study is available at https://clinicaltrials.gov.