Regeneron initiates enrollment in Phase III gout program

Regeneron Pharmaceuticals, a biopharmaceutical company, has initiated patient enrollment in the Phase III program evaluating the efficacy and safety of Arcalyst, also known as interleukin-1 trap, in the prevention of gout flares associated with the initiation of urate-lowering drug therapy and in the treatment of acute gout attacks.

This Phase III program with Arcalyst in gout was designed following discussions with the FDA. It will consist of four clinical studies. The North American-based Pre-Surge 1 study and the global Pre-Surge 2 study are each evaluating the number of gout flares per patient over the first 16 weeks of initiation of allopurinol therapy.

The global Surge study in patients experiencing an acute gout attack is evaluating pain during the initial 72 hours of treatment.

Arcalyst is approved in the US 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.

George Yancopoulos, president of Regeneron Research Laboratories, said: This comprehensive Phase III program reflects our enthusiasm for the potential role of Arcalyst therapy in these two gout patient populations. Initial data from this program are expected in 2010.