NeuroSense expands data in Phase IIb ALS study with positive update

Symptoms of amyotrophic lateral sclerosis (ALS) include hand and arm motor control loss and limb usage impairment. NeuroSense released additional top-line data from its PrimeC (celecoxib and ciprofloxacin) Phase IIb trial for ALS, including primary endpoint results. The Phase IIb PARADIGM trial (NCT05357950) met primary and secondary endpoints in December 2023, showing a 37.4% slower disease progression with PrimeC versus placebo, measured by the ALS Functional Rating Scale-Revised (ALSFRS-R).

ALS is a progressive neurodegenerative disease affecting nerve cells, leading to muscle control loss and paralysis. PrimeC activates DICER and inhibits COX-2, enzymes associated with ALS due to neuroinflammation and miRNA dysregulation.

Further PARADIGM analysis continues, with neurofilament results expected in Q1 2024 and TDP-43 and prostaglandinJ2 biomarker data in H1 2024.

Sanofi and Denali's Phase II HIMALAYA trial for SAR443820/DNL788 missed its primary endpoint, while Immunity Pharma's IPL244 Phase IIa trial showed positive results, advancing to Phase III. GlobalData's Pharma Intelligence Center predicts ALS cases to rise from 74,614 in 2019 to 80,483 by 2029, with an annual growth rate (AGR) of 0.79%.