NeuroSense Therapeutics is scheduled to meet with the U.S. Food and Drug Administration (FDA) on November 6 to discuss the plans for a Phase 3 clinical trial evaluating PrimeC as a treatment for amyotrophic lateral sclerosis (ALS). The meeting aims to align NeuroSense's clinical strategy with the FDA's requirements for a new drug application, potentially paving the way for PrimeC's approval.
PrimeC is a fixed-dose combination of ciprofloxacin, an antibiotic, and celecoxib, an anti-inflammatory drug, both already approved for other indications. The rationale behind PrimeC lies in its potential to modulate several biological processes implicated in ALS pathology, including inflammation, RNA processing, and iron accumulation. These processes are believed to contribute to the neurodegeneration observed in ALS patients.
Promising Phase 2b Results
NeuroSense is also pursuing early marketing approval for PrimeC in Canada, primarily based on the results of the Phase 2b PARADIGM trial (NCT05357950). This trial involved 68 adults with ALS who were randomized to receive either PrimeC or a placebo for six months, in addition to the standard ALS treatment, riluzole. Following the initial six-month period, almost all participants continued into an extension phase where all received active treatment with PrimeC.
Data from the PARADIGM trial and its extension demonstrated that patients who started on PrimeC in the main trial experienced a 36% slower disease progression and a 43% improvement in survival rates after one year, compared to those who initially received a placebo and then switched to PrimeC in the extension phase. These findings suggest a potential benefit of early PrimeC initiation in ALS patients.
MicroRNA Modulation
Recent biomarker data from NeuroSense indicates that PrimeC modulates the activity of microRNAs implicated in ALS. MicroRNAs are small non-coding RNA molecules that regulate gene expression. The company reported clear differences in microRNA responses between the PrimeC and placebo groups in the PARADIGM trial, suggesting that PrimeC may exert its therapeutic effects by restoring balance to these genetic regulators.
"By restoring balance to these genetic regulators, PrimeC offers a new method of combating this devastating disease," NeuroSense stated in a press release.
