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NeuroSense Announces Peer-Reviewed Publication of PrimeC Phase IIa ALS Study in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
Groundbreaking ALS biomarker research: Marks the first publication of NeuroSense's novel biomarker results demonstrating PrimeC's effect on ALS related
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"Groundbreaking ALS biomarker research: Marks the first publication of NeuroSense's novel biomarker results demonstrating PrimeC's effect on ALS related hallmarksPrimeC showed a statistically significant impact on key disease-related biomarkers including TDP-43, which increases with disease progression, and LC3, a key autophagy marker Based on successful Phase IIa results, NeuroSense commenced PARADIGM, a Phase IIb clinical trial in May 2022CAMBRIDGE, Mass., Sept. 19, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (\"NeuroSense\"), a company developing treatments for severe neurodegenerative diseases, today announced the peer-reviewed publication of Phase IIa clinical data in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration in a paper titled, \"Combination of ciprofloxacin/celecoxib as a novel therapeutic strategy for ALS\" authored by NeuroSense's Head of Scientific Program, Dr. Shiran Zimri, and Head of ALS Program, Avital Pushett, along with leading amyotrophic lateral sclerosis (ALS) researchers. View the paper in full here: LINK\n\n \n \n \n \n \n \n\n \nData in the paper are results from NeuroSense's Phase IIa study of its lead drug candidate, PrimeC, a unique and proprietary combination of two FDA-approved drugs—ciprofloxacin and celecoxib—in the treatment of ALS.\nKey data from the paper include:\nSafety:\nThe study met its primary endpoint of safety in a 12-month clinical trial with 15 participants living with ALS.Efficacy and Biomarkers:\nExploratory efficacy was evaluated by ALSFRS-R and FVC, and blood samples were taken before and during the study for biomarker analysis. PrimeC showed statistically significant changes in ALS-related biomarkers of serum neuron-derived exosomes (NDEs) such as TDP-43 and LC3 as measured by ExoSORT™ indicating a positive biological activity. The trial was open-label, comparing the data generated to the PROACT database utilizing propensity matching.Conclusions:\nThis study supports the safety and tolerability of PrimeC in ALS.Biomarker analyses suggest early evidence of a biological effect.\"This clinical study is a very important achievement and milestone for the ALS community. It is very encouraging to see that there was both biological activity and clinical signals of a treatment effect,\" said Vivian Drory, MD, Director of the Neuromuscular Diseases Unit ...