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European Medicines Agency Grants NeuroSense SME Status
SME status offers regulatory guidance and engagement in dialogue with EMANeuroSense to open an EU office in Ulm, GermanyCompany plans to enroll patients at
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"SME status offers regulatory guidance and engagement in dialogue with EMANeuroSense to open an EU office in Ulm, GermanyCompany plans to enroll patients at multiple sites across Europe in its planned Phase 3 pivotal ALS study of PrimeCCAMBRIDGE, Mass., Sept. 20, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (\"NeuroSense\"), a company developing treatments for severe neurodegenerative diseases, announced today 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.\n\nNeuroSense 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.\nThe 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.\nSME 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. \n\"SME status with the EMA comes at an opportune time for NeuroSense as we look ahead to clinical topline Phase 2b results with the expectation that it will lead us rapidly into a pivotal Phase 3 study for ALS,\" stated NeuroSense Founder and CEO, Alon Ben Noon. \"We plan to work closely with the EMA on the PrimeC development strategy towards the initiation of the Phase 3 study across Europe and appreciate their support of our mission in ALS.\" \nAbout NeuroSense\nNeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from de...