LX1032 is one of four programs in human clinical trials as part of Lexicon’s 10TO10 program. Having completed a single-dose Phase Ia clinical trial, Lexicon will initiate a multi-dose Phase Ib clinical trial of LX1032 in June 2008.
The Phase Ib trial is a randomized, double-blind, ascending multiple-dose study designed to evaluate the safety and tolerability of LX1032 in approximately 40 healthy volunteers. Lexicon expects data from the Phase Ib clinical trial before the end of 2008. Results from this study will be used to support the exploration of potentially therapeutic doses in patients with carcinoid syndrome in accordance with its fast track status.
Philip Brown, senior vice president of clinical development at Lexicon, said: “Gaining fast track status for LX1032 is an important step forward for our development plan. We believe that LX1032 may be an important new therapy to treat patients with carcinoid syndrome who have no other treatment options.”