European Medicines Agency Confers SME Status Upon NeuroSense

Thursday, September 21, 2023

NeuroSense Therapeutics Ltd. has unveiled plans to establish its EU office while also securing Small and Medium-Sized Enterprise (SME) status from the European Medicines Agency (EMA). NeuroSense is dedicated to developing treatments for severe neurodegenerative diseases, and this recognition from EMA offers significant advantages both before and after drug regulatory approval. Previously, EMA had granted PrimeC Orphan Drug Status for treating ALS.

In a significant milestone, NeuroSense successfully wrapped up patient enrollment for PARADIGM, its multinational Phase 2b clinical study focusing on PrimeC as a treatment for ALS. Notably, a substantial portion of the 69 enrolled patients were sourced from European sites. The company anticipates unveiling clinical topline results from PARADIGM by the end of 2023.

With an eye on the future, NeuroSense plans to initiate a global pivotal Phase 3 study for PrimeC in ALS during 2024, leveraging a substantial number of clinical sites across Europe. Recognizing Europe's importance as a key market, the company has strategically established an office in Ulm, Germany, to oversee regulatory interactions with EMA and effectively manage clinical operations during the Phase 3 study.

SME status carries several benefits, including regulatory guidance and early engagement with a multidisciplinary EMA team throughout the development program. Additionally, it provides financial advantages, such as a 100% fee reduction for scientific advice and facility inspections related to orphan products, along with a fee exemption during the first year following PrimeC's marketing authorization.

NeuroSense Founder and CEO, Alon Ben Noon, expressed his enthusiasm, stating, SME status with the EMA is perfectly timed for NeuroSense as we eagerly await clinical topline Phase 2b results, with the expectation that this progress will swiftly transition us into a pivotal Phase 3 study for ALS. We look forward to close collaboration with EMA in shaping the PrimeC development strategy for the forthcoming Phase 3 study across Europe, and we are grateful for their support in our mission to combat ALS.


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