The leading global supporter of type 1 diabetes (T1D) research JDRF has announced that it will support the development of a T1D drug developed by Woodlands-based Lexicon Pharmaceuticals by financing a phase 2, randomized, double-masked, placebo-controlled clinical trial. The tests will assess the efficacy and safety of LX4211 in younger patients suffering from the disease.
This collaboration is part of JDRF’s Glucose Control Research Program, which aims to develop and deliver improved insulin and non-insulin adjunct therapies that progressively improve glucose and overall metabolic control in individuals with T1D.
“JDRF has a strategic T1D research plan designed to deliver a sustained stream of new life-changing therapies, so we are pleased to collaborate with Lexicon on the development of LX4211 in T1D,” said JDRF’s assistant vice president for translational development, Sanjoy Dutta, Ph.D. “We believe that LX4211’s dual SGLT1/SGLT2 inhibitory mechanism offers an innovative and exciting opportunity to deliver on this goal and address an important unmet medical need in those with T1D struggling to achieve optimal glucose control target levels.”
The phase 2 trial will include 76 patients younger than 30 years old who suffer from type 1 diabetes and who have HbA1c levels greater than 9.0%. During the 12-week treatment period, the patients will be randomly assigned to be administered with either placebo or a once daily 400mg dose of LX4211. The drug is an oral, first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), developed to reduce blood glucose levels using two insulin-independent mechanisms of action.
Lexicon researchers will try to evaluate the superiority of LX4211 compared to placebo as adjunct to insulin treatment on HbA1c reduction at 12 weeks. As secondary endpoints they will also examine its efficiency in reducing the variability of blood glucose levels and lower the insulin needs.
“The results from our previous Phase 2 study of LX4211 in type 1 diabetes have encouraged us to also explore its potential application in this younger population for whom managing glucose variability is an especially difficult challenge and in which the significant majority are unable to achieve HbA1c targets,” explained Lexicon’s executive vice president and chief medical officer Pablo Lapuerta, M.D.
“Importantly, we hope to continue to see improvement in glycemic control with a longer treatment period combined with reductions in the amount of insulin required and related improvements in quality of life in this population of high unmet medical need. This study complements our ongoing preparations for Phase 3 in type 1 diabetes, which are proceeding, as well as our plans for LX4211 in type 2 diabetes,” he added.
Lexicon has announced several changes in the last few months. In January, the company announced a staff reduction to refocus its efforts in the late-stage drug development programs, especially LX4211, but also to prepare the commercialization of the products. Early this week, another executive transition was presented with the nomination of Lonnel Coats, former Chief Executive Officer of the Eisai’s U.S. subsidiary, as new President and CEO of Lexicon.