Late-stage clinical biotechnology company NeuroSense Therapeutics Ltd (NASDAQ:NRSN) announced on Monday that results from the Phase 2b clinical trial (PARADIGM) of PrimeC in people living with amyotrophic lateral sclerosis (ALS) have been published in JAMA Neurology.

PARADIGM was a randomised, double-blind, placebo-controlled trial that evaluated the safety, biological activity, and potential clinical effects of PrimeC during a 6-month blinded treatment period followed by a 12-month open-label extension.

PrimeC is a novel fixed-dose oral combination formulated in a synchronised extended-release composition designed to concurrently address three key mechanisms implicated in ALS progression: neuroinflammation, iron dysregulation, and microRNA-mediated regulatory pathways.

According to NeuroSense, the study showed a strong safety and tolerability profile and clinically meaningful functional outcomes. Continuous treatment with PrimeC was associated with slower functional decline and improved long-term outcomes, including a 7.92-point advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007) and significant improvement in bulbar function (P=0.001).

There was also a reduction in risk of major ALS complications, and biological evidence supporting disease modification.

The findings support the continued clinical development of PrimeC and its advancement to a confirmatory Phase 3 clinical trial in ALS.