With an eye on the FDA, Lexicon and Sanofi line up more positive data on diabetes drug
Lexicon Pharmaceuticals $LXRX is beefing up the positive data it’s been accumulating for the SGLT1/SGLT2 inhibitor sotagliflozin as it preps applications for Type 1 diabetes.
The inTandem2 study already demonstrated again that the drug significantly cut A1C in 24 weeks, and researchers can now point to fresh data underlining how that effect is sustained through the first full year of treatment. This study hit the primary and all secondary endpoints, including reduced weight and blood pressure. And it’s three for three in Phase III.
That’s also good news for Sanofi $SNY, which licensed the global rights to the drug. Just days ago Lexicon picked up co-commercialization rights in the all-important US market.
Lexicon is poised to pursue marketing approval in early 2018 — for both the US and European markets — for a novel drug that targets both SGLT-1 and SGLT-2. SGLT-2 drugs like Jardiance, Invokana and Farxiga have already made their mark on the market, blocking glucose absorption in the kidneys. But this therapy adds another target in the intestinal tract.
This drug may not revolutionize therapy, but in diabetes R&D — developing drugs for a mass audience of millions around the globe — every incremental step forward marks blockbuster potential.
Sanofi saw the promise and came in to bag the worldwide rights to the drug — leaving Lexicon with US co-promotion rights — with a $300 million upfront payment and $1.4 billion in potential milestones.
“Today’s results are exciting for so many people living with type 1 diabetes,” said Thomas Danne, head of diabetes at the Children’s Hospital on the Bult in Hannover, Germany and primary investigator for the inTandem2 clinical trial. “The observation that sotagliflozin significantly lowers blood glucose and favorably affects body weight and blood pressure without an increase in hypoglycemia strengthens the potential of the drug to become a first-in-class therapy in the treatment paradigm for type 1 diabetes.”