Sotagliflozin (LX4211) is an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), which could be a potential treatment option for diabetes patients.
It is currently being evaluated in two pivotal Phase 3 trials in type 1 diabetes. Phase 3 trials in type 2 diabetes are anticipated to start next year.
In exploratory (Phase 2) studies, sotagliflozin lowered blood sugar (HbA1c), improved glycemic variability and reduced meal-time insulin dose compared with placebo in type 1 diabetics.
Phase 2 studies in patients with type 2 diabetes, including those with renal impairment, demonstrated lowering of blood sugar (HbA1c), weight loss and blood pressure improvements.
Under the deal, Sanofi will pay Lexicon $300m. It also includes development, regulatory and sales milestone payments of about $1.4bn.
Lexicon is also eligible to tiered, escalating double digit percentage royalties of net sales of sotagliflozin.
Sanofi secures an exclusive worldwide license for the development, manufacture and commercialization of sotagliflozin.
Lexicon will responsible for all clinical development activities relating to type 1 diabetes and will retain an exclusive option to co-promote sotagliflozin in the US.
Sanofi will undertake all clinical development and commercialization activities of sotagliflozin to treat type 2 diabetes globally.
The company will be responsible to commercialize sotagliflozin for the treatment of type 1 diabetes outside the US.
Lexicon will share in the funding of a part of the planned type 2 diabetes development costs in the next three years.