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NeuroSense's Phase 2b ALS Trial Achieves Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints
Top-Line Results from 6-month double-blind Phase 2b PARADIGM trial with NeuroSense's lead drug candidate for ALS, PrimeC, include: PrimeC achieved primary
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"Top-Line Results from 6-month double-blind Phase 2b PARADIGM trial with NeuroSense's lead drug candidate for ALS, PrimeC, include: PrimeC achieved primary safety and tolerability endpoints with a safety and tolerability profile comparable to placeboMeaningful slowing of disease progression: 29% difference (P=0.12) in favor of ALSFRS-R outcome for patients treated with PrimeC vs placeboSlow Vital Capacity: observed a positive trend in favor of patients treated with PrimeC compared to placeboNeurofilament biomarker results from Biogen collaboration expected in January 2024Primary biomarker endpoints and exploratory biomarkers from this trial, expected in H1 2024Company to host webcast conference call to present data today at 8:30 AM ESTCAMBRIDGE, Mass., Dec. 5, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (\"NeuroSense\"), a company developing treatments for severe neurodegenerative diseases, today reported that it met its primary safety and tolerability endpoints and achieved secondary clinical efficacy endpoints in the top-line results of its randomized, placebo-controlled, double-blind segment the Company's Phase 2b amyotrophic lateral sclerosis (\"ALS\") trial of PrimeC (\"PARADIGM\"). The trial's secondary clinical efficacy outcome measure endpoints included Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (\"ALSFRS-R\") and Slow Vital Capacity (\"SVC\"), a measure of respiratory function. NeuroSense expects to report an additional primary biomarker endpoint of the assessment of ALS hallmarks, TDP-43 and Prostagladin2, to evaluate PrimeC's biological activity, in the first half of 2024 following the completion of the analysis of participants' plasma.\n\nThe PARADIGM (NCT05357950) trial is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b clinical trial of PrimeC in ALS. Participants living with ALS in Canada, Italy, and Israel were enrolled and dosed for 6 months after being randomized 2:1 to receive PrimeC or placebo, respectively. After completion of the 6-month double-blind segment, the participants had the option to enroll in a 12-month open label extension (OLE), during which they all receive treatment with PrimeC.\nOver the course of 6 months, patients treated with PrimeC experienced a slowing of disease progression, including preserved daily function. T...