ATI-355 / Novartis - LARVOL DELTA

Enhanced clinical trial stratification in spinal cord injury: the value of electrophysiology. (PubMed, Brain) - P2 | "We conducted a retrospective stratification analysis of data from the recently completed randomized, placebo-controlled, phase-2b Nogo Inhibition in SCI (NISCI) trial (NCT03935321) investigating the efficacy of NG101, a recombinant human antibody that neutralises the neurite outgrowth-inhibiting protein Nogo-A...This study shows the value of electrophysiology compared to clinical measures for biomarker-driven enrichment and improved power in acute SCI trials. We emphasize the importance of functionally spared neuronal pathways in promoting recovery in response to plasticity-inducing interventions like anti-Nogo-A antibodies."

Journal • CNS Disorders • Orthopedics

Safety and efficacy of intrathecal antibodies to Nogo-A in patients with acute cervical spinal cord injury: a randomised, double-blind, multicentre, placebo-controlled, phase 2b trial. (PubMed, Lancet Neurol) - P2 | "NG101 did not improve UEMS in patients with acute spinal cord injury. Post-hoc subgroup analyses assessing UEMS and Spinal Cord Independence Measure of self-care in patients with motor-incomplete injury indicated potential beneficial effects that require investigation in future studies."

Clinical • Journal • P2b data • CNS Disorders • Infectious Disease • Orthopedics

NISCI - Nogo Inhibition in Spinal Cord Injury (clinicaltrials.gov) - P2; N=114; Recruiting; Sponsor: University of Zurich; Trial completion date: Sep 2023 ➔ Dec 2023; Trial primary completion date: Sep 2022 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Complement-mediated Rare Disorders • Orthopedics

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) - P2; N=280; Recruiting; Sponsor: Neurogastrx, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Mar 2020 ➔ Aug 2020

Clinical • Enrollment open • Trial initiation date • Gastrointestinal Disorder