Business
NeuroSense Announces First Quarter 2022 Financial Results and Provides Business Update
CAMBRIDGE, Mass., May 31, 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., May 31, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (\"NeuroSense\"), a company developing treatments for severe neurodegenerative diseases, today reported its financial results for the quarter ended March 31, 2022 and provided a business update.\nBusiness Update\nInitiated Biomarker Studies for ALS and Alzheimer's disease \nThroughout Q1 2022, NeuroSense has been working vigorously to meet key drug development milestones. As an integral part of its clinical program, NeuroSense is pioneering the identification and use of novel disease related biomarkers in neurodegenerative diseases. During Q1 2022, the 3rd stage of the Company's amyotrophic lateral sclerosis (ALS) biomarker study was initiated in collaboration with Massachusetts General Hospital (MGH) in Boston, and a new study on Alzheimer's disease (AD) biomarkers also commenced. Results from both studies are expected in Q2 2022.\nReceived FDA Clearance of IND for PrimeC in Treatment of ALS\nNeuroSense continues to advance its regulatory strategy via the U.S. Food and Drug Administration (FDA). In Q1 2022, the FDA cleared NeuroSense's Investigational New Drug (IND) application to initiate a pharmacokinetic (PK) study of PrimeC, its lead combination drug candidate developed for the treatment of ALS. In addition, a Fast Track application was submitted to the FDA and not granted at this time. The Company is planning to resubmit the application upon further generation of data. PrimeC was previously granted Orphan Drug Designation by the FDA and EMA. \nCommenced Enrollment and Dosing in U.S. PK Study of PrimeC for ALS\nIn April 2022, NeuroSense enrolled and dosed the first healthy volunteer in its PK study (NCT05232461) of PrimeC. The PK open-label, randomized, single-dose, three-treatment, three-period crossover study is evaluating the effect of food on the bioavailability of PrimeC as compared to the bioavailability of co-administered ciprofloxacin tablets and celecoxib capsules in 12 healthy adult subjects in the U.S. under an FDA cleared IND protocol. Data are expected in Q3 2022. The combined data from both this PK study and the Company's upcoming Phase IIb ALS study will assist in designing a pivotal Phase III trial of PrimeC for the treatment of ALS in alignment with FDA requirements.\nOn Track to Initiate Phase IIb PrimeC Study for AL...