Curis, Inc. announced that Amylin Pharmaceuticals filed an Investigational New Drug (IND) application with the US Food and Drug Administration in late December to initiate clinical studies with the compound AC162352 (PYY 3-36) for the potential treatment of obesity. In an announcement, Amylin Pharmaceuticals stated that it plans to initiate its first Phase 1 study of this compound in the first quarter of this year.

In December of 2002 Curis licensed and assigned patents covering the use of PYY, a peptide made in the gut, to Amylin for the in vivo treatment of metabolic diseases, including diabetes and obesity. Clinical research published earlier this year in Europe demonstrated that administration of PYY to humans could suppress appetite and reduce food intake, suggesting that PYY may have therapeutic potential in the growing obesity market.

The agreement between Curis and Amylin Pharmaceuticals provides for an up-front licensing fee and additional milestone cash payments from Amylin Pharmaceuticals to Curis, based primarily upon obtaining regulatory approval and sales goals, and a royalty on future product sales. Amylin is solely responsible for development and testing of the PYY compound.

The agreement with Amylin covers a subset of Curis' PYY patent applications that relate to the use of PYY for the treatment of metabolic diseases, such as diabetes and obesity. Curis retains rights to other PYY patent applications that relate to the use of PYY to transform stem cells into insulin-producing cells and other types of specialized cells.

Daniel Passeri, Curis' president and CEO, said, "Curis would like to congratulate Amylin on the submission of this IND application. This IND filing is the first of what we hope will be several IND filings involving Curis licensees and Curis technology over the next 12 to 18 months."