NeuroSense Receives Positive FDA Feedback on Phase 3 Study Design for PrimeC

NeuroSense Therapeutics (NRSN) announced that it has concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) for PrimeC in the treatment of amyotrophic lateral sclerosis (ALS). The purpose of the meeting was to discuss the design of a proposed Phase 3 clinical study and the plan for submission of an eventual 505(b)(2) marketing application. The Company had a productive discussion with the FDA regarding the design of the planned Phase 3 pivotal study with PrimeC, including efficacy and safety measurements. The Type C meeting with the FDA, combined with the recent 18-month Phase 2b PARADIGM study readout, has NeuroSense Therapeutics (NRSN) on track to commence a Phase 3 study in mid-2025.

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