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Prime-C News Release
According to the study, “Combination of ciprofloxacin/celecoxib as a novel therapeutic strategy for ALS,” published in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, and funded by NeuroSense Therapeutics, Prime C was found to be well tolerated and effective at decreasing biomarkers of the disease in an open-label Phase 2 clinical trial conducted in Israel from 2019 and 2020.
Ciprofloxacin and Celecoxib
“a novel therapeutic strategy for ALS”
Overview:
The small study was aimed at evaluating safety and tolerability of a fixed-dose co-formulation of ciprofloxacin and celecoxib, referred to as PrimeC, in ALS patients.
Findings:
Study shows promising initial findings regarding safety, tolerability and potential efficacy.
Biomarker analyses:
Significant changes in levels of neural-derived exosomal TDP-43, neurofilament levels and LC3, a key autophagy marker were found. Biomarker analyses suggests early evidence of a biological effect.
Adverse Events:
No serious AEs were attributed to PrimeC.
Next Steps:
Larger, placebo-controlled study is underway to examine efficacy, with the potential to become a new drug candidate for ALS.
Citation:
Beaulieu D, Ennist DL, Berry JD, Paganoni S, Shefner JM, Drory VE. Combination of ciprofloxacin/celecoxib as a novel therapeutic strategy for ALS. Amyotroph Lateral Scler Frontotemporal Degener. 2023 May;24(3-4):263-271. doi: 10.1080/21678421.2022.2119868. PMID: 36106817.
current trial status:
Participants that have been diagnosed for 30 months or less were randomly assigned to receive PrimeC or a placebo for six months. There is an open label extension, for another six months.