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NeuroSense Announces Positive PrimeC Toxicology Data Supportive of Current Phase IIb PARADIGM ALS Clinical Trial
PrimeC is safe and tolerable at over 4x the maximal clinical dose Data support current Phase IIb PARADIGM study design, new PrimeC formulation, and potential
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"PrimeC is safe and tolerable at over 4x the maximal clinical dose Data support current Phase IIb PARADIGM study design, new PrimeC formulation, and potential favorable clinical trial outcomeCAMBRIDGE, Mass., Sept. 20, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (\"NeuroSense\"), a company developing treatments for severe neurodegenerative diseases, today announced positive results from its Good Laboratory Practices (GLP) toxicology study designed to evaluate the toxicological profile and toxicokinetics of the combination of celecoxib and ciprofloxacin, the components of PrimeC, the Company's lead combination drug candidate for the treatment of amyotrophic lateral sclerosis (ALS). PrimeC is a novel extended-release oral formulation composed of a unique fixed-dose combination of the two drugs, which are U.S. Food and Drug Administration (FDA)-approved. NeuroSense is currently evaluating PrimeC in PARADIGM, a Phase IIb clinical trial.\n \n\"In concluding the FDA requirement to carry out a 90-day GLP toxicology study in rodents, we can be reassured that the clinical doses of celecoxib and ciprofloxacin, being used in our novel formulation, are safe and tolerable. We plan to share the data we have obtained with the FDA as part of PrimeC's drug development plan,\" stated Diana Shtossel, Head of Regulatory Affairs at NeuroSense. \"These highly encouraging results support the safety profile we have already seen, as well as the likelihood of a favorable outcome from our ongoing Phase IIb PARADIGM trial.\"\nThe GLP study tested the combination of celecoxib and ciprofloxacin, administered by oral gavage to Sprague-Dawley rats twice daily, for a period of 90 consecutive days. The body weights, body weight gains, and food consumption were unaffected by the treatment at all the doses tested. There were no test item-related changes observed in hematology, coagulation, clinical chemistry, urinalysis, organ weights, gross pathology and histopathology, and neurological examinations. Animals treated with celecoxib alone, ciprofloxacin alone, or in combination, up to the highest doses tested did not show any adverse toxicological effects. In conclusion, the No Observed Adverse Effect Level (NOAEL) is over 4x the maximal clinical dose.\n\"With this toxicology study, we achieved another meaningful milestone in our PrimeC developm...