Sanofi has announced top-line data from three Phase III clinical trials performed to assess Zynquista (sotagliflozin) in adults with type 2 diabetes.
Discovered by Lexicon Pharmaceuticals, Zynquista is an oral dual inhibitor of sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2) proteins involved in glucose regulation.
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In the SOTA-MET trial, a 400mg dose of the drug was observed to cause a statistically significant reduction in HbA1c at 26 weeks in patients on metformin, compared to placebo.
HbA1c is a measure of blood sugar control.
Data from the SOTA-CKD3 study also demonstrated a statistically significant HbA1c decrease in all subjects with stage 3 chronic kidney disease (CKD) who received 400mg Zynquista, versus placebo, at 26 weeks.
Similar results were observed in the subpopulation of patients who had a glomerular filtration rate of 45-<60 mL/min/1.73m2 or stage 3A CKD.
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By GlobalDataHowever, the drug failed to achieve statistical significance in those with a glomerular filtration rate of 30-<45 mL/min/1.73m2 or stage 3B CKD.
Both the 200mg and 400mg doses of the drug also failed to reach statistical significance compared to placebo at 26 weeks in CKD4 patients enrolled in the SOTA-CKD4 trial.
Safety analysis did not reveal any new signals across the three Phase III studies, which are part of the InSynchrony type 2 diabetes Phase III Zynquista programme.
Sanofi said that, based on the HbA1c data from the SOTA-CKD3 and SOTA-CKD4 trials, it decided to terminate its alliance with Lexicon to develop, manufacture, and commercialise the drug in all ongoing type 1 and type 2 diabetes programmes.
The company added that ongoing Phase III studies will not see any immediate changes.
Commenting on the decision, Lexicon said that the termination notice will be considered invalid as its collaboration and licence agreement requires Sanofi to transition rights and continue the funding of ongoing trials for a specified period after termination.
Lexicon Pharmaceuticals president and CEO Lonnel Coats said: “In the event of a valid termination of the Sanofi alliance, we will also look forward to regaining full rights to Zynquista in type 1 diabetes in the US, as well as rights in the remainder of the world, notably including the European Union, in which Zynquista has already received approval.”
