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AD/PD 2023 | Key findings from Phase IIa study of PrimeC in ALS patients

Shiran Salomon-Zimri, PhD, NeuroSense Therapeutics, Herzliya, Israel, explains the key results from the Phase IIa open-label study (NCT04165850) of PrimeC in 12 patients with amyotrophic lateral sclerosis (ALS). PrimeC combines celecoxib and ciprofloxacin, hoping to target numerous aspects of the disease pathophysiology at once through its multitargeted activity. After the 12-month treatment period, a trend towards improvement was noted in the ALS Functional Rating Scale-Revised (ALSFRS-R) and forced vital capacity (FVC). To quantify this, participants were matched with control patients from the PRO-ACT database via propensity matching. This found an 18% effect on ASLFRS-R scores, as well as a 30% effect on respiratory function. These clinical findings, combined with biomarker evidence (a significant reduction in TDP-43 and prostaglandin 2), supported the establishment of the PARADIGM study (NCT05357950). PARADIGM is a Phase IIb multicenter, placebo-controlled study of 69 patients treated with extended-release PrimeC for 6 months. This interview took place at the AD/PD™ 2023 congress in Gothenburg, Sweden.

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