NG101 nonsuperior to placebo at 6 months in cervical spinal cord injuries

Key takeaways:

• Change from baseline to 6 months in both patient groups were similar by Upper Extremity Measurement Scale scores.
• NG101 was generally safe with no treatment-related deaths reported.

For individuals with recent acute cervical spinal cord injuries, treatment with a novel neuroregenerative therapeutic was nonsuperior to placebo after 6 months, according to research published in The Lancet Neurology.

“A clear unmet need exists for effective interventions to improve clinical outcomes for people with spinal cord injury,” Norbert Weidner, MD, medical director of the Spinal Cord Injury Center in Heidelberg, Germany, and colleagues wrote. “Neuroregenerative therapies aim to promote axonal regrowth or neutralize endogenous molecules that inhibit such growth.

Weidner and colleagues evaluated the efficacy of intrathecal administration of NG101, a recombinant human antibody that promotes neural repair and motor recovery, in patients with acute cervical traumatic spinal cord injury in a randomized, double-blind, placebo-controlled phase 2b clinical trial conducted at 13 hospitals in the Czech Republic, Germany, Spain and Switzerland from May 2009 to July 2022.

From an initial screening cohort of 463 adults with acute traumatic cervical spinal cord injury, 129 individuals within a 4- to 28-day injury window were randomly assigned (NG101 group, n = 80; placebo group, n = 49) to receive either 45 mg of NG101 or matching placebo. At the 18-month mark, randomization was adjusted to a 3:1 ratio to improve enrollment and boost exposure to the novel therapeutic.

Administration was planned as six intrathecal injections every 5 days over a period of 4 weeks, beginning within 4 weeks of spinal injury. All participants had MRI taken at 3 intervals: initial screening, day 30 and day 168.

The study’s primary endpoint was change in Upper Extremity Measurement Scale (UEMS) from baseline to day 168, along with safety readings from the 126 individuals comprising full analysis set, which included 78 individuals from the NG101 group and 48 given placebo. Among these, seven patients from the NG101 group and four from the placebo group did not receive full dosing.

Results showed no significant difference between patient groups with respect to UEMS change at 6 months (95% CI –1.44 to 4.18). Scores for those given placebo progressed from 19.2 at baseline to 30.91 by day 168 and within the NG101 group, scores ranged from 18.23 at baseline to 31.31.

The researchers further reported that 25 severe adverse events were recorded among study participants: 18 were recorded in 11 patients in the NG101 group and seven among six patients in the placebo group.

Infections were the most common adverse event, affecting 44 patients in the placebo group and 65 from the NG101 group, while no treatment-related deaths were recorded.

“This study showed no evidence of efficacy of anti-Nogo-A treatment with NG101 across the entire population, including patients with motor-complete injury,” Weidner and colleagues wrote.