ATI-355 / Novartis - LARVOL DELTA

Lost in translation: why pharmacological trials keep failing in acute spinal cord injury. (PubMed, Arq Neuropsiquiatr) - "The current narrative review critically examines the seven agents evaluated in phase-II to -III clinical trials-methylprednisolone (MPSS), GM-1 monosialotetrahexosylganglioside, minocycline, riluzole, anti-Nogo-A antibody NG101, VX-210, and granulocyte colony-stimulating factor (G-CSF)-with emphasis on quantitative effect estimates, confidence intervals, and mechanisms of translational failure. The Nogo Inhibition in Spinal Cord Injury (NISCI) trial (2025), the most methodologically rigorous SCI trial to date, demonstrated no primary endpoint benefit but identified functional signals in motor-incomplete injuries. In total, six structural domains of translational failure are identified and methodological solutions proposed."

Journal • Review • CNS Disorders • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Orthopedics • Respiratory Diseases

The Integrated Neurological Change Score Is a Sensitive Neurological Composite Measure to Evaluate Cervical Spinal Cord Injury Trials. (PubMed, J Neurotrauma) - "The NISCI trial assessed the safety and efficacy of the anti-Nogo-A antibody (NG-101) in acute cervical SCI, reporting a potential therapeutic effect in motor incomplete patients...Finally, INCS correlates strongly with functional outcomes in self-care and walking ability, outperforming ISNCSCI motor scores. In conclusion, the INCS represents a sensitive measure of neurological change corroborating the value of ISNCSCI standards for use in SCI trials."

Clinical • Journal • CNS Disorders • Orthopedics

Anti-Nogo-A NG101 treatment induces changes in spinal cord micro- and macrostructure following spinal cord injury. (PubMed, Nat Commun) - P2 | "Combining MRI with electrophysiology enables sensitive detection of treatment effects and efficient trial designs. ClinicalTrials.gov identifier: NCT03935321."

Clinical • Journal • CNS Disorders • Orthopedics

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