Ever since Woodlands, Texas-based Lexicon Pharmaceuticals‘ strategic pivot back in January in order to focus on the company’s late-stage drug development for its telotristat etiprate for carcinoid syndrome and other indications, the company has continued to move aggressively toward finalizing the enrollment process for its current pivotal Phase 3 trial of LX4211. After having published a clinical pipeline review back in March indicating steady progress in enrollment for the current clinical trial and plans to begin commercialization efforts, the company has now posted a new report highlighting successes in the ongoing Phase 3 trial, as well as an updated financial summary.
According to a Lexicon press release, Dr. Arthur T. Sands, president and CEO of Lexicon, reports that, “Consistent with our focus on late-stage drug development, we have made continued, excellent progress in the enrollment of patients in our pivotal Phase 3 trial for telotristat etiprate for carcinoid syndrome,”and adding, “We are also looking forward to advancing LX4211 into later-stage development in type 1 diabetes based on the very encouraging results of our recently completed Phase 2 study.”
This new news concerning the current progress of LX4211 in clinical trials joins a recent report from earlier in the month that revealed promising top-line results for the drug in a Phase 2 clinical trial that tested its effectiveness in functioning as a dual inhibitor of sodium-glucose transporters 1 and 2 for patients diagnosed with type 1 diabetes. In that study, Lexicon reported that LX4211 met the primary endpoint, which was to effectively reduce mealtime insulin use for type 1 diabetics. The study also indicated that the drug achieved several secondary endpoints as well, such as improved glycemic control in participants.
The study, which was designed as a placebo-controlled, double-blind, 28-day study in order to produce the most accurate results possible, showed that LX4211 managed to reduce total daily mealtime bolus insulin doses by 32% compared to 6% for placebo (p=0.007), while the therapy also significantly improved glycemic control with a mean HbA1c reduction of 0.55% in the LX4211-treated group, compared to a reduction of only 0.06% with placebo (p=0.002), according to the press release. Lexicon went on to report that:
“These results were accompanied by significant improvement in the time spent in a target glucose range of 70-180 mg/dl, a significant reduction in time in hyperglycemic range, and no increase in hypoglycemia. Multiple measures indicated that LX4211 treatment resulted in reduced variability in blood glucose levels. Overall, LX4211 was well tolerated with no discontinuations of study medication due to adverse events. Lexicon plans to meet with the FDA to discuss the potential advancement of LX4211 into Phase 3 development for type 1 diabetes.”
While Lexicon most recent clinical pipeline review includes positive data for LX4211’s use in treating type-1 diabetes, the company also indicated that they are still pro-actively pursuing rigorous recruitment efforts to complete enrollment for Telotristat etiprate (LX1032), an experimental therapy for carcinoid syndrome that acts as an inhibitor of tryptophan hydroxyls (TPH), which reduces peripheral serotonin production without affecting brain serotonin levels. The company believes that it will complete enrollment for this clinical trial, entitled TELESTAR, by late 2014.