Regeneron initiates Ph III Arcalyst study

The USA's Regeneron Pharmaceuticals has initiated patient enrollment in a Phase III program evaluating the efficacy and safety of Arcalyst  (rilonacept), also known as interleukin-1 Trap, in the prevention of  gout flares associated with the start of urate-lowering drug therapy.

Arcalyst is approved in the USA for the treatment of  cryopyrin-associated periodic syndromes, including familial cold  auto-inflammatory syndrome and Muckle-Wells Syndrome in adults and  children 12 and older.

This trial in gout was designed following discussions with the US Food  and Drug Administration. It will consist of four clinical studies. The  North American-based PRE-SURGE 1 study and the global PRE-SURGE 2 trial  are each evaluating the number of gout flares per patient over the first  16 weeks of initiation of allopurinol, which is used to reduce serum  uric acid levels in gout patients.