NervGen receives FDA breakthrough therapy status for SCI drug
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The FDA granted Breakthrough Therapy designation to NervGen's NVG-291 for chronic traumatic cervical motor-incomplete spinal cord injury.
MIAMI -- NervGen Pharma announced today that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to NVG-291 for treating chronic traumatic cervical motor-incomplete spinal cord injury.
The designation was granted based on safety and efficacy data from the chronic cohort of the Phase 1b/2a CONNECT SCI study, according to a press release statement. The study showed improvements in functional hand use among individuals with chronic traumatic cervical motor-incomplete spinal cord injury. NVG-291 was generally well tolerated, with no serious adverse events or treatment discontinuations reported.
Breakthrough Therapy designation is intended to expedite development and review of drugs treating serious conditions where preliminary clinical evidence indicates potential substantial improvement over available therapy. Benefits include eligibility for Priority Review and rolling submission of New Drug Application sections.
The company’s Phase 3 RESTORE registrational study is currently enrolling participants, with site activation continuing in the United States and Canada. The multicenter, randomized, double-blind, placebo-controlled study expects to enroll approximately 150 participants. The primary endpoint assesses improvement in hand function as measured by GRASSP Quantitative Prehension.
Eligible participants are one to ten years following a traumatic spinal cord injury, have a motor level at C7 or higher on both sides, and have an American Spinal Injury Association Impairment Scale classification of C or D. Participants will be randomized to receive NVG-291 or placebo by once-daily subcutaneous injection for 12 weeks, followed by a four-week observation period.
Approximately 312,000 people in the United States are living with traumatic spinal cord injury, with about 18,500 new injuries occurring annually. There are currently no FDA-approved pharmacologic therapies to restore lost neurologic function in individuals living with chronic spinal cord injury.
NVG-291 is designed to target the inhibitory CSPG-PTPσ pathway. The drug has previously received Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency for spinal cord injury treatment.
