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MADRID, 23 Mar. (EUROPA PRESS) –
The European Medicines Agency (EMA) has designated an orphan drug to a compound based on the bioactive lipid molecule maresin 1 (MaR1) that is being studied by a research team from the Universitat Autònoma de Barcelona (UAB) for the treatment of spinal cord injury.
According to the university, the designation represents an important step to advance the development of a potential new treatment, recognizing that MaR1 could provide a relevant clinical benefit in an area with high unmet medical need.
Spinal cord injuries have an estimated incidence of between 20 and 45 cases per million inhabitants per year. There is currently no pharmacological treatment that improves neurological recovery after damage; The only drug approved in the acute phase is methylprednisolone, the use of which is discouraged in many countries due to its adverse effects and limited effectiveness.
The UAB explains that MaR1 is a lipid produced by macrophages (cells of the immune system) during the resolution phase of inflammation and acts by promoting the completion of the inflammatory process and the protection of the tissue. The treatment being investigated by the Neuroplasticity and Regeneration Group of the Institut de Neurociències (INc-UAB) and the Department of Cellular Biology, Physiology and Immunology of the UAB, led by Rubèn López, has demonstrated in animal models an outstanding capacity to significantly reduce post-injury inflammation and promote processes that limit neurodegeneration. These actions translate into a substantial improvement in locomotor recovery.
“This designation is recognition of many years of research in the biology of inflammation resolution and in models of spinal cord injury, and allows us to move forward towards the goal of one day being able to offer a therapy to people who suffer from this serious condition,” said López.
The center highlights that the designation of an orphan drug by the EMA means enjoying regulatory advantages that speed up the development of the compound, such as priority scientific advice or accelerated evaluation pathways, and protects the exclusivity of marketing if it reaches the market.
To advance towards a clinical trial with the treatment, the UAB indicates that the regulatory preclinical studies that guarantee the safety of the product must be completed and a fully validated manufacturing process must be established, as well as waiting for the approval of the documentation presented by the research team by the regulatory agency and the ethics committee. All of these steps require approximately three to five years of work before a trial in patients can begin.
The research carried out by the UAB research team is funded by the Ministry of Science, Innovation and Universities, the la Caixa Foundation, the Agency for Management of University and Research Grants (AGAUR) and Barcelona Activa, in addition to the University’s own funds.
