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July 21, 2014
08:18 EDTRGLSRegulus Therapeutics granted orphan drug designation for RG-012 by FDA
Regulus Therapeutics announced that the FDA has granted orphan drug designation to RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21, as a therapeutic for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy. In the near term, Regulus expects to initiate a natural history of disease study to gather further information about the progression of Alport syndrome and to inform future clinical development plans of RG-012, a key program under Regulus' 'Clinical Map Initiative'.
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September 18, 2014
08:07 EDTRGLSRegulus Therapeutics initiates ATHENA study in Alport syndrome patients
Regulus Therapeutics has initiated its ATHENA natural history of disease study in patients with Alport syndrome, a life-threatening genetic kidney disease with no approved therapy. The ATHENA study is designed to characterize the natural decline of renal function markers such as Glomerular Filtration Rate, creatinine, proteinuria and beta-2 microglobulin, in Alport syndrome patients over time. The data collected from the ATHENA study will provide information about the changes in renal function over time in Alport syndrome patients, which will inform future clinical development plans of Regulus' RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21, currently in development to treat renal dysfunction in Alport syndrome patients.

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