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AD/PD 2023 | Novel combination therapy PrimeC in ALS: biomarker data & launch of Phase II trial

Shiran Salomon-Zimri, PhD, NeuroSense Therapeutics, Herzliya, Israel, introduces Prime: an investigational therapy being studied in neurodegenerative disorders, such as amyotrophic lateral sclerosis (ALS). PrimeC is a combination of celecoxib and ciprofloxacin that work synergistically to improve both the pharmacokinetics (PK) and efficacy of each drug, compared to when used individually. Given the evidence of efficacy in preclinical models of ALS, Dr Salomon-Zimri & her team wished to assess the impact of PrimeC on key ALS-related biomarkers, to further elucidate its mode of action. Using neuron-derived exosomes from patients treated with PrimeC for 12 months in the open label Phase IIa study, changes in biomarkers were assessed over time and in comparison to a matched, standard-of-care-treated cohort. Significant changes in several biomarkers were seen following treatment with PrimeC, compared to controls, including TDP-43, PGJ2, and LC3. A further study in post-mortem brain tissue will look to validate these findings by investigating the impact of PrimeC on mechanisms such as autophagy, mitochondrial function, and oxidative stress. Given these findings, the upcoming multicenter, Phase IIb PARADIGM study (NCT05357950) will use PGJ2 and TDP43 as the primary outcome measures. This interview took place at the AD/PD™ 2023 congress in Gothenburg, Sweden.

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