Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it is progressing into the placebo-controlled portion of its Phase 2 clinical trial of LX4211 in patients with type 1 diabetes, having successfully completed the open-label, pioneer portion of the trial. LX4211 is an investigational, oral, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2).
The pioneer phase of the study was designed to gain important initial information regarding the safety of co-administration of LX4211 with insulin in this, the first test of dual inhibition of SGLT1 and SGLT2 in patients with insulin-dependent type 1 diabetes. The successful conclusion of the 28-day pioneer group enables the initiation of the placebo-controlled expansion phase of the study to commence in up to 30 patients with type 1 diabetes. Based on the results observed in the pioneer group, Lexicon has identified the 400 mg once daily dose of LX4211 as the appropriate treatment for the expansion phase of the trial.
"This is a very important first step in the future development of LX4211 in type 1 diabetes," said Dr. Arthur Sands , president and chief executive officer of Lexicon. "The preliminary results are very encouraging and provide a strong rationale for moving into the expansion phase of the trial."
LX4211, a first-in-class dual inhibitor, reduces the amount of glucose that enters the bloodstream from the gastrointestinal (GI) tract by inhibiting SGLT1, the major transporter responsible for glucose absorption, and enhances glucose excretion in the urine by inhibiting SGLT2, the major transporter responsible for glucose reabsorption by the kidney. Lexicon has previously demonstrated that SGLT1 inhibition by LX4211 increases GLP-1 and PYY, GI hormones associated with glycemic control and appetite. Lexicon is also developing LX4211 for type 2 diabetes with Phase 3 planning ongoing.
Lexicon Pharmaceuticals, Inc.