Melbourne-based Neuren Pharmaceuticals (ASX:NEU) announced that IP Australia has issued a Notice of Grant for a new patent that covers the use of trofinetide for the treatment of Autism Spectrum Disorders, including Rett syndrome, Fragile X syndrome, Asperger syndrome and autism.
Patent number AU2012209466 expires in January 2032. The new patent derives from an international patent application filed in 2012.
Neuren has patent applications pending in the United States, Europe, Canada, Japan, Brazil and Israel, all of which are derived from the same international application.
According to Neuren executive chairman, Richard Treagus, “The grant of this patent is commercially important and timely for two reasons. Firstly, Neuren now has an issued patent that protects trofinetide for Rett syndrome and Fragile X syndrome in the Australian market. Secondly it is the first patent to be granted from a series of applications in the major pharmaceutical markets that cover the use of trofinetide broadly in Autism Spectrum Disorders until 2032.”
Neuren is in Phase 2 development of trofinetide as a new therapy for Rett syndrome and Fragile X syndrome. The second Phase 2 trial in Rett syndrome, which is enrolling children and adolescents, is presently underway.
Both the Rett syndrome and Fragile X syndrome programs have been granted Fast Track designation by the US Food and Drug Administration and have orphan drug designation in both the US and the European Union. Following marketing authorisation, orphan drug designation provides a market exclusivity period of 7 years in the United States and 10 years in the European Union.