Lexicon announces additional positive Phase III data for diabetes drug
Lexicon Pharmaceuticals has reported additional positive data from its Phase III inTandem2 clinical trial of sotagliflozin in adult type 1 diabetes patients on a background of optimised insulin.
Sotagliflozin is an investigational dual inhibitor of sodium-glucose linked transporter1 (SGLT1) and SGLT2.
In previously reported results, inTandem2 demonstrated a statistically significant decrease in A1C at 24 weeks, and the new data suggested sustained A1C benefit over 52 weeks.
Additionally, the data showed achievement of all secondary endpoints of net benefit, body weight, bolus insulin use, fasting plasma glucose (FPG), diabetes treatment satisfaction questionnaire status (DTSQs) score, and two-item diabetes distress screening scale (DDS2) questionnaire score.
The double-blind, placebo-controlled, multi-centre Phase III trial evaluated 200mg and 400mg of sotagliflozin once-daily in 782 subjects across Europe and Israel.
Both doses have shown encouraging data during the trial, while the 400mg dose significantly decreased systolic blood pressure (SBP).
Lexicon Pharmaceuticals executive vice-president and chief medical officer Pablo Lapuerta said: “InTandem2 is the second pivotal study to demonstrate sotagliflozin’s ability to durably improve both A1C and other key measures of health such as body weight and blood pressure in patients with type 1 diabetes.
“Today’s results underscore sotagliflozin’s benefit / risk profile and highlight its differentiated profile in the type 1 diabetes landscape.”
Sotagliflozin was observed to be generally well tolerated during the 28-week extension period, and the rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and discontinuations due to AEs were consistent with rates in the initial 24-week treatment period.
In 2015, Lexicon obtained an exclusive worldwide (except Japan) right and licence from Sanofi to develop, manufacture and commercialise sotagliflozin.