29 July 2019 | News
Sanofi has expressed willingness to work with Lexicon to ensure a smooth transition of the studies
Sanofi has announced topline results from three Phase 3 trials of ZynquistaTM (sotagliflozin) in adults living with type 2 diabetes from the InSynchrony clinical program. Given the primary endpoint results of blood sugar control (HbA1c) reduction in the SOTA-CKD3 and SOTA-CKD4 studies, Sanofi provided notice to Lexicon that it is terminating the collaboration to develop, manufacture, and commercialize Zynquista in all ongoing global type 1 and type 2 diabetes programs.
At this time, the ongoing Phase 3 clinical trials will continue and there will be no immediate changes. Sanofi has expressed willingness to work with Lexicon to ensure a smooth transition of the studies. Sanofi remains committed to working and supporting the investigators and patients enrolled in the studies while next steps are discussed with Lexicon.
Topline results of the three studies are as follows:
No imbalances or new safety signals were observed in these studies.