Business
NeuroSense Announces Third Quarter 2022 Financial Results and Provides Business Update
CAMBRIDGE, Mass., Dec. 1, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing treatments for severe
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"CAMBRIDGE, Mass., Dec. 1, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (\"NeuroSense\"), a company developing treatments for severe neurodegenerative diseases, today announced its financial results for the quarter ended September 30, 2022 and provided a business update.\n\"During and immediately following the end of the third quarter, NeuroSense achieved multiple milestones, including FDA acceptance of our IND and approval from the Italian Medicines Agency allowing us to commence patient enrollment in the U.S. and Europe for our Phase 2b ALS study, which we expect to begin in the coming weeks. With over $8.4 million in cash and short-term deposits on our balance sheet at the end of Q3, we believe we are well positioned to complete our Phase 2b study and report topline results during Q3 2023,\" stated NeuroSense's CEO, Alon Ben-Noon. \"In our multi-dose pharmacokinetic study, which highlighted PrimeC's novel formulation and enhanced PK profile, we observed favorable synergism between the compounds, we believe further confirming our Phase 2b study design.\"\nBusiness Update\nFDA Acceptance of IND to Commence Patient Enrollment in the U.S. and AIFA Approval to Commence Patient Enrollment in ItalyNeuroSense achieved several milestones during Q3 in the clinical development plan for PrimeC, currently being evaluated in PARADIGM, a double-blind, placebo-controlled, multi-center Phase 2b clinical trial. Over 40% of the patients necessary to complete the trial have been enrolled. Upon the recent announcement that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) and the approval received from the Italian Medicines Agency (AIFA), patient enrollment is expected to commence for PARADIGM in the U.S. and Europe in the next few weeks. \nSynergism Observed in Multi-Dose PK Studies with PrimeCIn Q3, NeuroSense released results from a multi-dose pharmacokinetic (PK) study (NCT05436678). The PK open-label, randomized, multi-dose, three-treatment, three-period crossover study evaluated the effect of food on the bioavailability of PrimeC as compared to the bioavailability of co-administered ciprofloxacin tablets and celecoxib capsules in adult subjects in the U.S. under an FDA-cleared IND protocol. Based on results, we believe the PK profile of PrimeC supports the formulation's ...