About this video

• Video Title: Breakthrough spinal injury drug shows promise
• Channel: FOX 32 Chicago
• Speakers: Anita Flores, Dr. Adam Rogers
• Duration: 00:13:47

Overview

This video discusses a new experimental drug, NVG-291, developed by Nerve Gen, that shows promise in improving motor function for individuals with spinal cord injuries. Dr. Adam Rogers, CEO of Nerve Gen, explains the drug's development, results from a Phase 1b/2a clinical study, and the next steps, including a larger Phase 3 study. The discussion highlights the significant impact of spinal cord injuries and the lack of effective pharmacological treatments, emphasizing the potential of NVG-291 to restore function and improve the quality of life for patients.

Key takeaways

• Spinal cord injuries affect over 300,000 individuals in the U.S., with 18-19,000 new cases annually, and currently lack effective pharmacological treatments to improve function.
• Nerve Gen has developed an experimental drug, NVG-291, which is administered as a daily injection for 12 weeks and has shown significant improvement in hand and upper arm function in a Phase 1b/2a clinical study.
• The study observed a doubling of improvement in upper arm function and a 9.3% improvement in hand function over 12 weeks, even in individuals who were 1 to 10 years post-injury.
• The drug's effectiveness is particularly notable as it has shown functional improvement in individuals with severe spinal cord injuries, a population that is currently underserved in terms of treatment options.
• Nerve Gen is planning to initiate a larger Phase 3 study in mid-2026 across multiple sites to further validate the drug's efficacy and safety, with an anticipated timeline of approximately 24 months after the first patient enrollment for regulatory approval.

Here are the claims made by the CEO, Dr. Adam Rogers:

• Drug Efficacy: He claims that the experimental drug NVG-291 can help improve the process of regaining movement for individuals with spinal cord injuries.
• Addressing a Need: He states that there are no current pharmacologic treatments (drugs) that individuals can take to improve function after a spinal cord injury, except for some approved electrical stimulation devices.
• Study Results: He reports that in a Phase 1b/2a clinical study, patients treated with NVG-291 showed a doubling of improvement in upper arm function and a 9.3% improvement in hand function over 12 weeks compared to the control group.
• Patient Demographics: He highlights that the study included individuals with cervical spinal cord injuries, specifically C7 and higher, who were considered motor-complete and had some, but very limited, hand and leg movement. He also notes that participants were 1 to 10 years post-injury, with an average of over 4 years since the injury.
• Importance of Hand Function: He asserts that for individuals in wheelchairs, hand function is considered the most important factor for regaining independence and improving quality of life, often more so than walking.
• Drug Administration: He explains that NVG-291 is administered as a simple daily injection in the abdomen for 12 weeks.
• Future Plans: He states that the company is moving towards a Phase 3 study, which will be larger and conducted at multiple sites, aiming for regulatory approval.
• Potential for Combinational Therapy: He suggests that in the future, NVG-291 might be used in combination with some form of stimulation for a multimodal approach to treatment.
• Drug Development Challenges: He acknowledges that drug development is a time-consuming and expensive process that requires patience.
• Patient Impact: He expresses confidence that the drug will dramatically impact the lives of individuals with spinal cord injuries, providing hope and transforming their lives.
• Current Study Enrollment: He mentions that there is an active ongoing study at the Shirley Ryan Ability Lab enrolling individuals up to 90 days post-cervical spinal cord injury who are motor-complete.

The video transcript mentions walking in the context of prioritizing functional improvements for individuals with spinal cord injuries. Dr. Adam Rogers states that when asked what is most important to someone in a wheelchair, regaining hand function is often considered more vital than walking. He explains this by highlighting the daily activities that rely on hand dexterity, such as using a computer mouse, typing, transferring oneself, eating independently, and holding a phone. While walking is an important goal, the immediate needs and daily functionalities provided by improved hand movement are emphasized as critical for independence.