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Monday, 03/21/2022 7:17:07 PM

Monday, March 21, 2022 7:17:07 PM

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NeuroSense surges on FDA nod to study ALS candidate in healthy subjects
Mar. 21, 2022 9:03 AM ETNeuroSense Therapeutics Ltd. (NRSN)

By: Dulan Lokuwithana, SA News Editor



Israel-based, clinical-stage biotech, NeuroSense Therapeutics (NASDAQ:NRSN) has added ~32% in the pre-market Monday after announcing that the U.S. Food and Drug Administration (FDA) greenlighted a pharmacokinetic study for its lead asset, PrimeC in healthy adult subjects.
An oral combination of FDA-approved drugs, ciprofloxacin, and celecoxib, PrimeC is designed to target amyotrophic lateral sclerosis (ALS).
With its Investigational New Drug (IND) application, NeuroSense (NRSN) has sought the FDA nod to run a pharmacokinetic study to evaluate the effects of food on the bioavailability of PrimeC as opposed to the bioavailability of co-administered ciprofloxacin and celecoxib. The Phase 1 study is set to involve 12 healthy adults in the US.
NeuroSense (NRSN) has already completed a successful Phase IIa trial for the candidate, and a Phase IIb global study is expected to start in Q2 2022.

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