NeuroSense’s groundbreaking treatment, PrimeC, aims to regulate microRNA synthesis, reduce neuroinflammation, and affect iron accumulation. In preclinical studies in SOD1 and TDP-43 zebrafish mutant models, the treatment benefitted motor performance, motor neuron morphology, neuromuscular junction structure, and morphology of microglia cells.
Following the successful preclinical studies, NeuroSense initiated a 12-month open label clinical trial in 15 patients to determine the safety of PrimeC. The study also analyzed the efficacy of PrimeC by observing patients’ overall and respiratory functions. A virtual control group was used to predict each subject’s deterioration. Interim results of the study showed that patients taking PrimeC had a reduced deterioration in respiratory and overall function compared to the virtual control group, suggesting efficacy of PrimeC.
Following these preliminary results, NeuroSense plans to initiate a placebo-controlled clinical trial, which may lead to an NDA application.