Lexicon builds case for Sanofi-partnered diabetes pill

Lexicon Pharmaceuticals has bolstered the case for its Sanofi-partnered diabetes pill. The latest update means Lexicon now has data from two phase 3 trials showing the effect of the SGLT1-SGLT2 inhibitor sotagliflozin on A1C in patients with Type 1 diabetes is sustained over 52 weeks.

The new data come from inTandem2, the second of Lexicon’s three successful phase 3 studies. The trial reported top-line success in cutting levels of blood glucose biomarker A1C over 24 weeks late last year. And the Europe-focused clinical trial has now followed its North America-based sibling, inTandem1, in showing the effects seen at 24 weeks are sustained through to 52 weeks.

Woodlands, Texas-based Lexicon’s release disclosing the 52-week inTandem2 results is light on data. Rather, it describes the 0.34% to 0.36% placebo-adjusted drops in A1C seen after 24 weeks as being "sustained" over the course of the extension.   

Lexicon also provided an update on the secondary endpoints, stating both doses of sotagliflozin beat placebo against the six additional goals tracked by the trial. The secondary endpoints include body weight, bolus insulin use and fasting plasma glucose. Those readouts offered encouragement to those championing sotagliflozin.

"The observation that sotagliflozin significantly lowers blood glucose and favorably affects body weight and blood pressure without an increase in hypoglycemia strengthens the potential of the drug to become a first-in-class therapy in the treatment paradigm for Type 1 diabetes," Thomas Danne, M.D., the primary inTandem2 investigator, said in a statement.

Data generated to date have encouraged Lexicon and Sanofi to broaden and advance their plans for the drug. Sanofi is penciled in to start a clutch of phase 3 trials in patients with Type 2 diabetes in the second half of the year as it seeks to use sotagliflozin to help fend off competition in a key market for the company.

That effort will take a step forward next year when Sanofi files for approval of sotagliflozin in Type 1 diabetes in the U.S. and Europe. Sanofi is due to make those filings in the first half of next year, potentially as early as the first quarter.