NeuroSense Therapeutics Ltd. announced that it has opened an EU Office as well as been granted the Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency (EMA), which offers significant benefits leading up to and following drug regulatory approval. The EMA already granted PrimeC Orphan Drug Status for the treatment of ALS. NeuroSense completed enrollment in PARADIGM, its Phase 2b multinational clinical study of PrimeC for the treatment of ALS.

One-third of the 69 enrolled patients came from sites located in Europe. Clinical topline results from PARADIGM are expected at the end of 2023. The Company expects to commence a global pivotal Phase 3 study of PrimeC in ALS in 2024 with a vast number of clinical sites in Europe.

As Europe is a key market, in addition to the USA, NeuroSense has opened an office in Ulm, Germany to lead its regulatory dialogue with the EMA and clinical operations during the planned Phase 3 study. SME status offers benefits, including regulatory guidance and engagement in early dialogue with a multidisciplinary EMA team throughout the development program. In addition, financial benefits such as a 100% fee reduction for scientific advice and inspections of facilities for orphan products, as well as a fee exemption following marketing authorization of PrimeC in its first year of sales.