About this Video

• Video Title: NervGen Pharma Virtual Investor Event
• Channel: Hz1.618
• Speakers: Mike Kelly, Dr. Steven Kershum, Dr. Monica Perez, Dan Michael, Bill Adams
• Duration: 01:01:20

Introduction

This virtual investor event presents NervGen Pharma's clinical program and its lead product, NBG291, a treatment for spinal cord injuries. The presentation includes overviews of spinal cord injuries, the clinical trial design, and future development plans following the upcoming data readout.

Key Takeaways

• NBG291's pre-clinical success: Animal studies showed remarkable neural repair and motor function recovery using NBG291R (rodent version).
• Phase 1B/2A clinical trial underway: This trial assesses NBG291's efficacy and safety in patients with acute and chronic cervical spinal cord injuries. Recruitment is complete for the chronic cohort, and the subacute cohort is underway.
• Primary outcome measurements: The trial uses electrophysiology (measuring brain-muscle connectivity) and clinical assessments (motor function tests) to evaluate efficacy.
• Data readout imminent: The first human data readout is expected within 60 days of the presentation.
• Post-data readout plans: The company will analyze patient characteristics, safety data, efficacy (focusing on electrophysiological changes and functional improvements), and plan next steps (potentially accelerated approval or a Phase 3 trial) in consultation with the FDA. They also have a fast-track designation.
• Expanded Access Program: NervGen has updated its expanded access policy to allow provision of NBG291 to eligible patients under certain conditions and with FDA approval.

Based on the transcript, the standard of care for SCI patients includes:

• Hospitalization: One to two weeks in an acute hospital.
• Inpatient rehabilitation: Four to six weeks of comprehensive inpatient rehabilitation.
• Outpatient therapy: Several months of outpatient therapy following inpatient rehabilitation.

The transcript does not provide further details on the types of therapies included in inpatient and outpatient rehabilitation, only that they aim to maximize the patient's capabilities based on their remaining motor strength and manage medical complications.

The most common adverse event in the Phase 1 trial of NBG291 in healthy participants was injection site related. There were no other adverse events that were increased in the NBG291 group compared to the placebo group, and no serious adverse events in the NBG291 treatment group. There was also no effect on other clinical parameters such as vital signs, laboratory tests, or electrocardiograms. All subjects completed the treatment.