Lexicon Initiates Phase 2 Clinical Trial For LX4211

Lexicon Pharmaceuticals (Lexicon) has initiated a phase 2 clinical trial of the drug candidate in patients with type 2 diabetes mellitus. LX4211 is an orally-delivered, small molecule drug candidate that inhibits the sodium glucose transporter 2 (SGLT2).

Reportedly, in the recently completed phase 1 clinical trial in normal healthy volunteers, LX4211 was well tolerated at all dose levels and produced a dose-dependent increase in urinary glucose excretion. Additionally, LX4211 has also demonstrated a favorable pharmacokinetic profile supporting the potential for once daily dosing.

Based on the phase 1 clinical results, Lexicon has initiated a phase 2 clinical trial to evaluate the safety and tolerability of two dose levels of LX4211 and its effect on diabetes biomarkers including: fasting blood glucose, urinary glucose excretion and response to oral glucose tolerance testing in patients with type 2 diabetes.

The company said that the four-week, randomised, double-blind, placebo-controlled study will be conducted in the US and is expected to enroll 36 patients with type 2 diabetes.

Brian Zambrowicz, executive vice president and chief scientific officer at Lexicon, said: “LX4211 offers an opportunity to treat diabetes by increasing urinary glucose excretion through a mechanism of action that is expected to avoid some of the disadvantages of existing diabetes drugs that result in storage of excess glucose. By contrast, LX4211 through inhibition of SGLT2 has the potential to reduce caloric load and thereby enhance overall glucose homeostasis in patients with type 2 diabetes.”