Sanofi and Lexicon Pharmaceuticals, Inc., recently announced the start of a new partnership and license agreement for the development and commercialization of sotagliflozin, a novel orally-delivered investigational dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), for the possible treatment of patients with diabetes.
“This agreement with Lexicon reinforces our commitment to helping people living with diabetes,” said Pascale Witz, Executive Vice President, Sanofi, who will lead the Global Diabetes and Cardiovascular Care Business Unit in the company’s new organizational structure, in a recent press release. “Adding sotagliflozin to our portfolio, which includes medicines at virtually every stage of the treatment pathway, highlights our focus on providing a large and diverse set of therapeutic options for people with this disease.”
Sotagliflozin (LX4211) is being evaluated in two distinct pivotal Phase 3 clinical trials in patients with type 1 diabetes. The results from these trials are expected for the second semester of 2016. In addition, the beginning of Phase 3 clinical trials in patients with type 2 diabetes is also planned for 2016.
The investigational medicine has demonstrated positive results in exploratory Phase 2 clinical trials, such as a reduction in the levels of blood sugar (HbA1c), an improvement in glycemic variability, and a reduction in the meal-time insulin dose in comparison to placebo in patients with type 1 diabetes.
Results from Phase 2 trials investigating sotagliflozin in patients with type 2 diabetes involving patients suffering from renal complications revealed that the treatment resulted in weight loss, a reduction in the levels of blood sugar (HbA1c), and an improvement in blood pressure. During the Phase 2 study, no increase in hypoglycemic events with sotagliflozin was observed in comparison with background therapy. Adverse events were found to be identical to other medicines in this class and linked to the urinary glucose excretion known to be related to sotagliflozin’s inhibition of SGLT-2.
“Lexicon firmly believes in the potential of sotagliflozin for patients living with diabetes. It has been our strategy to focus our resources on the development of sotagliflozin for type 1 diabetes and to pursue a strategic partnership with respect to type 2 diabetes only if it would strengthen stakeholder value under a fully integrated diabetes program. We believe this arrangement with Sanofi achieves that objective,” explained Lexicon President and Chief Executive Officer Lonnel Coats. “Sanofi’s patient-centric focus in diabetes, and its rich history of innovation in diabetes, make it an exceedingly attractive partner which is well positioned to unlock the full potential of sotagliflozin for patients living with diabetes. Also consistent with our strategy, Lexicon will continue to lead the development of sotagliflozin for type 1 diabetes and have rights to participate in the commercialization of sotagliflozin for type 1 diabetes in the United States.”
Lexicon will receive an upfront payment of $300 million from Sanofi and is entitled to development, sales and regulatory milestone payments in a total of up to $1.4 billion. The company is also eligible to tiered royalties of net sales of the medicine. Sanofi has worldwide exclusivity for the development, manufacturing, and commercialization of sotagliflozin.
Sotagliflozin inhibits both sodium-glucose cotransporter type 2, or SGLT2, a transporter responsible for most of the glucose reabsorption performed by the kidney, and sodium-glucose cotransporter type 1, or SGLT1, a transporter responsible for glucose and galactose absorption in the gastrointestinal tract.