NurExone Biologic Inc. has successfully completed a preclinical study of its ExoPTEN treatment for spinal cord injuries, demonstrating significant improvements in motor function recovery and blood flow at the injury site in two different dosing regimens. This positive data supports the company’s planned Investigational New Drug (IND) application, a crucial step towards initiating first-in-human clinical trials. The study’s success reinforces the potential of ExoPTEN to address a significant unmet medical need in spinal cord injury treatment, a market with limited effective therapies.
This advancement is particularly important because it provides further validation of ExoPTEN’s mechanism of action, which aims to promote tissue repair and functional recovery by improving blood flow and nutrient delivery to the damaged area. The observed increase in blood vessel size following ExoPTEN administration suggests enhanced circulation, a key factor in healing and restoring function after spinal cord injury. This focus on improving blood flow offers a novel approach to treatment, potentially differentiating ExoPTEN from existing therapeutic options.
The preclinical study compared a single high dose of ExoPTEN administered on the day of surgery with a lower dose given over five consecutive days. Both regimens demonstrated significant improvements in motor function compared to the control group, as measured by the BBB locomotor rating scale. Histological analysis confirmed the increase in average blood vessel size in the treated groups, supporting the hypothesis that ExoPTEN enhances vascularization and, consequently, functional recovery.
This successful preclinical study is a major step forward for NurExone and brings ExoPTEN closer to clinical evaluation. The data strengthens the company’s position as it prepares its IND application and moves towards first-in-human trials. Positive clinical results could significantly impact the spinal cord injury treatment landscape, offering new hope for patients and potentially establishing ExoPTEN as a leading therapeutic option in this underserved market. Continued progress in the preclinical program will further refine ExoPTEN’s therapeutic profile and pave the way for regulatory approvals and eventual commercialization.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.