Biotechnology company ReNetX Bio Inc reported on Wednesday the receipt of US Food and Drug Administration (FDA) approval to proceed with the Investigational New Drug (IND) application for its lead drug candidate, fusion protein AXER-204 for the treatment of chronic spinal cord injury (SCI).

Effective immediately, the company will begin the recruitment of patients for the Phase 1 first-in-human trial of AXER-204 for chronic spinal cord injury (SCI). The 'RESET' Trial will assess safety, tolerability, pharmacokinetics and efficacy in patients at leading SCI treatment centres across the US.

ReNetX Bio's technology on blocking inhibitory proteins to promote regrowth of neurons was developed by its founder and scientific advisor Stephen Strittmatter, MD, PhD, Vincent Coates Professor of Neurology at Yale University. Three proteins were identified as key inhibitors preventing neural regrowth due to binding with NgR1 (Nogo Pathway). These new neural connections enable rewiring and reversal of damage in the central nervous system.

According to the company, AXER-204 has generated positive results in numerous preclinical disease models, which have been independently validated in leading academic and industrial labs. Treatment with AXER-204 resulted in significant regrowth of nerve fibres and increased functionality -- including axonal regeneration, axonal sprouting and synaptic plasticity -- even many months after injury or damage, with no toxicological findings.

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) through the BrIDGs Programme (Bridging Interventional Development Gaps) and the Wings for Life Spinal Cord Research Foundation has supported the company to advance the SCI programme into the clinic.