NurExone's ExoPTEN Achieves 100% Motor Function Recovery in Spinal Cord Injury Preclinical Study
核心洞察
NurExone Biologic's ExoPTEN demonstrated complete motor function recovery in 100% of animals receiving high-dose treatment following spinal cord injury, compared to only one animal in the untreated control group.
The dose-ranging study revealed significant improvements in walking quality metrics including paw print areas, contact duration, and base of support, indicating enhanced balance, strength, and coordination.
The treatment showed excellent tolerability with no observed side effects at the highest dose, supporting the company's plans to advance toward first-in-human clinical trials.
NurExone Biologic Inc (搜索). has announced breakthrough preclinical results showing that 100% of animals treated with a higher dose of ExoPTEN regained motor function after spinal cord injury. The preliminary dose-ranging study, confirmed using the CatWalk XT system, represents a significant milestone for the company's regenerative exosome-based therapy program.
Dose-Dependent Motor Recovery Demonstrated
The study compared medium and high single doses of ExoPTEN, administered minimally-invasively on the day of spinal cord compression surgery, against a control group receiving vehicle injection only. Results showed a clear dose-dependent effect, with 100% of animals in the high-dose group regaining walking ability in both hind limbs, compared to 50% in the medium-dose group, and only 1 out of 6 rats in the untreated control group.
"This is a significant milestone for our program," said Dr. Tali Kizhner, Director of Research and Development at NurExone. "Seeing the animals regain the ability to walk, with measurable improvement in locomotion function, is incredibly exciting. The CatWalk XT provided us with objective data that strengthens the scientific foundation for ExoPTEN's potential to restore function after an acute spinal cord injury."
Comprehensive Gait Analysis Reveals Functional Improvements
The gait analysis data demonstrated dose-dependent improvement in walking function across multiple parameters. Animals treated with higher doses of ExoPTEN displayed larger paw print areas, greater maximal contact area of their hind paws, a wider base of support, and extended duration of paw contact with the walkway. These indicators reflect improved balance, strength, coordination and weight bearing during walking.
The CatWalk XT system, developed by Noldus Information Technology (搜索), uses an illuminated glass walkway to capture footprints and movement patterns, allowing researchers to collect precise, objective data on animal motor function. The system is widely considered a leading tool for studying animal movement.
Safety Profile and Next Steps
Notably, the high dose was well tolerated, with no observed side effects. Evaluation of additional study parameters is ongoing. The company plans to initiate additional studies to explore alternative dosing regimens while advancing the optimization of ExoPTEN's manufacturing processes and analytical methods. These efforts aim to refine the drug's therapeutic profile and facilitate engagement with regulatory authorities.
NurExone continues to advance its research and development efforts, optimizing ExoPTEN's dosing strategies and manufacturing processes, and preparing for regulatory submissions as it aims to launch first-in-human clinical trials.
About ExoPTEN and Market Potential
ExoPTEN is NurExone's lead product candidate, an exosome-based therapy that has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both representing multi-billion-dollar markets. The company has obtained Orphan Drug Designation, facilitating the roadmap towards clinical trials in the U.S. and Europe.
NurExone Biologic Inc (搜索). is a TSX Venture Exchange, OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. The company has established Exo-Top Inc (搜索)., a U.S. subsidiary, to anchor its North American activity and growth strategy.