Lexicon developing type 1 diabetes treatment with Sanofi

All patients with type 1 diabetes have to take insulin, while some people with type 2 diabetes can manage their condition with diet and exercise, according to the American Diabetes Association. Photo credit: J H Lancy/Haymarket Medical

Type 2 diabetes has been hogging health headlines lately — and for good reason. The disease plagues more than 422 million people globally and is growing.

However, type 1 diabetes, typically diagnosed in children and young adults, is also on the rise. The autoimmune disease is characterized by the body's inability to produce insulin and is not linked to diet.

Lexicon Pharmaceuticals' sotagliflozin is in Phase III trials for type 1 and type 2 diabetes. If approved, the drug will initially impact type 1 diabetes most significantly as the first oral adjunctive therapy to insulin. In November 2015, Lexicon struck a development deal with Sanofi, through which Lexicon will continue to lead the development of sotagliflozin and retain rights to participate in the drug's U.S. commercialization.

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Sotagliflozin's dual SGLT1 and SGLT2 inhibition may represent a novel treatment option for patients with type 1 diabetes. Based on clinical results to date, it could greatly reduce the daily burden on these individuals, says Dr. Paul Strumph, Lexicon's VP of clinical development and development lead for sotagliflozin.

The dual inhibitor disrupts the process by which glucose is transported around the body and redirects excess blood sugar to be excreted in the urine.

“SGLT inhibition lowers blood glucose independent of insulin and is therefore complementary to insulin treatment,” Strumph explains.

Adds Dr. Jerry Lee, VP, group director of science and medicine at the agency Digitas Health LifeBrands, “If sotagliflozin can demonstrate A1C improvement and reduction in severe hypoglycemic events, then I envision it being adopted into the standard of care regimen for type 1 diabetes.”

A Phase III trial (inTandem1) of sotagliflozin as adjunct to insulin therapy for type 1 diabetes patients demonstrated a significant reduction in A1C at 24 weeks without an increase in severe hypoglycemia.

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“While diabetic ketoacidosis (DKA) was reported in both treatment groups, the FDA has acknowledged DKA risk with SGLT2 inhibitor use,” notes Michael Kuhn, VP of market access at GfK Health. A previous Phase II study showed improvement in glycemic control and a reduction in need for mealtime insulin in patients with type 1 diabetes.

“Patients with diabetes represent a heterogeneous population with diverse treatment challenges,” explains Lee. He believes providers will welcome another option in their arsenal.

On the payer side, highly prevalent, chronic conditions with costly complications that comprise a significant portion of a payer's total spend are an attractive target for disease-management programs, Lee says.

“If a new branded medication can tell a convincing value story grounded in strong clinical outcomes, it's likely to be well received by the payer audience.”

CORRECTION: An earlier version of this article incorrectly cited the agency that Dr. Jerry Lee works for. He is VP and group director of science and medicine at the agency Digitas Health LifeBrands.