NeuroSense Receives FDA Feedback On Phase 3 Study Design For PrimeC; NeuroSense Plans Phase 3 ALS Trial Of PrimeC With FDA Protocol Submission In H1 2025; Study To Enroll 300 Patients Starting Mid-2025, Featuring 12-Month Treatment Followed By 12-Month Open-Label Extension

• The Type C meeting with the FDA, combined with the recent 18-month Phase 2b PARADIGM study readout, has the Company on track to commence a Phase 3 study in mid-2025
• PrimeC has already demonstrated a significant impact on slowing disease progression and increasing survival rates in people living with ALS

CAMBRIDGE, Mass., Dec. 11, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced 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 FDA's positive feedback and guidance on overall trial design marks a noteworthy achievement for NeuroSense, as alignment on the design is a critical step in enabling the study to meet regulatory expectations and potentially provide sufficient data for the drug's approval.

In light of the FDA's feedback, NeuroSense plans to submit a final protocol to the FDA during the first half of 2025 with the aim of commencing enrollment of the pivotal Phase 3 study in mid-2025, which would include approximately 300 patients divided by a ratio of 2:1, PrimeC to placebo. The Phase 3 study is expected to be a randomized, multi-center, multinational, prospective, double-blind, placebo-controlled study, with an open label extension (OLE), to evaluate the efficacy and safety of PrimeC in people living with ALS. Following 12 months of treatment, it is expected that all participants will transition to PrimeC for a 12-month OLE.