AXER-204 / ReNetX Bio - LARVOL DELTA

Pharmacological intervention for chronic phase of spinal cord injury. (PubMed, Neural Regen Res) - "This review presents some of these candidates that have shown promising outcomes in basic research (in vivo animal studies) and clinical trials: AA-NgR(310)ecto-Fc (AXER-204), fasudil, phosphatase and tensin homolog protein (PTEN) antagonist peptide 4, chondroitinase ABC, intracellular sigma peptide, (-)-epigallocatechin gallate, matrine, acteoside, pyrvate kinase M2, diosgenin, granulocyte-colony stimulating factor, and fampridine-sustained release. Although the current situation suggests that drug-based therapies to recover function in chronic spinal cord injury are limited, potential candidates have been identified through basic research, and these candidates may be subjects of clinical studies in the future. Moreover, cocktail therapy comprising drugs with varied underlying mechanisms may be effective in treating the refractory status of chronic spinal cord injury."

Journal • CNS Disorders • Muscular Atrophy • Orthopedics • Transplantation • PTEN

Development of neural repair therapy for chronic spinal cord trauma: soluble nogo receptor decoy from discovery to clinical trial. (PubMed, Curr Opin Neurol) - "NgR1 signaling restricts neurological recovery in animal studies of CNS injury. The recent clinical trial of AXER-204 provides encouraging signals supporting future focused trials of this neural repair therapeutic. Further, AXER-204 studies provide a roadmap for the development of additional and synergistic therapies for chronic SCI."

Clinical • Journal • Review • CNS Disorders • Orthopedics

Soluble Nogo-Receptor-Fc decoy (AXER-204) in patients with chronic cervical spinal cord injury in the USA: a first-in-human and randomised clinical trial. (PubMed, Lancet Neurol) - P1/2 | "This study delivers the first, to our knowledge, clinical trial of a rationally designed pharmacological treatment intended to promote neural repair in chronic SCI. AXER-204 appeared safe and reached target CSF concentrations; exploratory biomarker results were consistent with target engagement and synaptic stabilisation. Post-hoc subgroup analyses suggest that future trials could investigate efficacy in patients with moderately severe SCI without prior AXER-204 exposure."

Journal • P1 data • Cardiovascular • CNS Disorders • Orthopedics • Pain

RESET: AXER-204 in Participants With Chronic Spinal Cord Injury (clinicaltrials.gov) - P1/2 | N=52 | Completed | Sponsor: ReNetX Bio, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Orthopedics

RESET: AXER-204 in Participants With Chronic Spinal Cord Injury (clinicaltrials.gov) - P1/2; N=56; Active, not recruiting; Sponsor: ReNetX Bio, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • CNS Disorders • Orthopedics • MRI

RESET: AXER-204 in Participants With Chronic Spinal Cord Injury (clinicaltrials.gov) - P1/2; N=56; Recruiting; Sponsor: ReNetX Bio, Inc.; Trial completion date: Dec 2021 ➔ Jun 2022; Trial primary completion date: Jul 2021 ➔ Jun 2022

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

Nogo receptor decoy promotes recovery and corticospinal growth in non-human primate spinal cord injury. (PubMed, Brain) - "A soluble decoy (NgR1-Fc, AXER-204) blocks these ligands and provides a means to promote recovery of function in multiple preclinical rodent models of spinal cord injury...The data show that NgR1-Fc does not have preclinical toxicological issues in healthy animals or safety concerns in spinal cord injury animals. Thus, it presents as a potential therapeutic for spinal cord injury with evidence for behavioural improvement and growth of injured pathways in non-human primate spinal cord injury."

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