NeuroAiD (MLC601/MLC901; Moleac) has a favourable safety profile and promising benefits as an add-on therapy to patients suffering from severe spinal cord injuries (SCIs) and, as such, a future controlled clinical trial is justified.
This is according to the results of the SATURN study, published online in the Journal of Spinal Cord Medicine by Ramesh Kumar (Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia) et al.
The study included patients with American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B in an open-label cohort study. Each received a course of NeuroAiD for six months in addition to standard care and rehabilitation. Key endpoints were safety, AIS grade and motor scores at six months.
Among 30 patients included (mean age 42.2 ± 17.6 years, 24 men), 20 patients had AIS A while 10 patients had AIS B at baseline. Ten patients experienced 14 adverse events including one serious adverse event and six deaths, none of which however were considered treatment-related.
In all, 33% of patients improved their AIS score at month 6 from baseline, with improvement in 25% and 50% of patients in the AIS A and AIS B groups, respectively. Additionally, the ASIA total motor score improved over time from 17.1 at baseline to 49.9 at month six.
Of note, the investigators point out that the improvement rates during the six-month course of NeuroAiD appear to be higher than the previously reported spontaneous recovery rates of approximately 10% from grade A to grade B and 10 % at grade C, 80% of patients remaining at grade A.
“Any improvement in AIS grading is clinically important for SCI patients,” said Kumar. “The rates of improvement we saw at six months in our study with NeuroAiD in this severe SCI sample with excellent safety, are very encouraging to use and to develop it as a complementary therapeutic option.”