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. 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 study is available at https://clinicaltrials.gov.