US-based biopharmaceutical firm Lexicon Pharmaceuticals has reported positive top-line results from the Phase III inTandem3 clinical trial of sotagliflozin to treat type 1 diabetes patients on any background insulin therapy.
Sotagliflozinan is an investigational, oral dual inhibitor of sodium-glucose co-transporter type 1 and 2 (SGLT1 and SGLT2) proteins involved in glucose regulation.
SGLT1 regulates glucose absorption in the gastrointestinal tract, while SGLT2 manages glucose re-absorption by the kidney.
The trial met the primary endpoint of superiority over placebo in the proportion of patients with less than 7% of glycosylated A1C at week 24, without any episode of severe hypoglycemia and diabetic ketoacidosis (DKA) following randomisation.
The randomised, double-blind, placebo-controlled, parallel-group, multi-centre Phase III trial evaluated 400mg of once-daily sotagliflozin in 1,402 patients who were on continuous subcutaneous insulin infusion or multiple daily injection therapy with an A1C level of 7%-11% during enrolment.
Lexicon president and CEO Lonnel Coats said: "These positive results represent an important milestone, further supporting sotagliflozin's differentiated profile as a novel, oral anti-diabetic agent with potential to benefit people with type 1 diabetes.
"Sotagliflozin is the first-ever oral anti-diabetic drug candidate to have achieved success in now three consecutive Phase III clinical trials in this population."
The drug candidate showed a well-tolerated safety profile and the rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and discontinuations due to AEs were found to be consistent with the previous Phase III inTandem1 and inTandem2 trials.
Under the collaboration and licence agreement signed with Sanofi in November 2015, Lexicon granted the firm with an exclusive, worldwide (excluding Japan) right and licence to develop, manufacture and commercialise sotagliflozin.