NeuroSense Therapeutics (NRSN) said Monday its phase 2b trial of its lead drug candidate PrimeC in amyotrophic lateral sclerosis met its primary efficacy endpoint, showing a "statistically significant" decrease in TDP-43 levels compared with placebo at day 180.
The decrease in TDP-43, recognized as the pathological signature of ALS, gives biological evidence that PrimeC is engaging a core disease mechanism, the company said, adding that the reduction was sustained through 18 months.
NeuroSense said that after obtaining US Food and Drug Administration clearance to start a global phase 3 trial, it is advancing trial preparations and engaging with regulators in several jurisdictions, including Canada.
PrimeC is an oral formulation composed of FDA-approved ciprofloxacin and celecoxib.
NeuroSense shares were up more than 8% in Monday trading.
Price: $0.82, Change: $+0.06, Percent Change: +8.27%